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A Study to Evaluate the Efficacy and Safety of TG-2349 in Combination With Peg-interferon and Ribavirin in Subjects With Chronic Hepatitis C Virus Genotype 1b Infection

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ClinicalTrials.gov Identifier: NCT02340962
Recruitment Status : Completed
First Posted : January 19, 2015
Results First Posted : October 12, 2018
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
TaiGen Biotechnology Co., Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C, Chronic
Interventions Drug: TG-2349
Drug: Ribavirin
Drug: Interferon Alfa-2a
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group I Group II
Hide Arm/Group Description 200 mg TG-2349 (2 capsules) + Interferon or Peg-interferon + Ribavirin 400 mg TG-2349 (4 capsules) + Interferon or Peg-interferon + Ribavirin
Period Title: Overall Study
Started 13 12
Completed 12 12
Not Completed 1 0
Reason Not Completed
Lost to Follow-up             1             0
Arm/Group Title Group I Group II Total
Hide Arm/Group Description 200 mg TG-2349 (2 capsules) + Interferon or Peg-interferon + Ribavirin 400 mg TG-2349 (4 capsules) + Interferon or Peg-interferon + Ribavirin Total of all reporting groups
Overall Number of Baseline Participants 13 12 25
Hide Baseline Analysis Population Description
Full Analysis Set (FAS) population includes subjects with genotype 1b HCV infection who were enrolled and received at least one dose of study drugs.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 12 participants 25 participants
50.8  (10.76) 54.0  (11.91) 52.3  (11.21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 12 participants 25 participants
Female
8
  61.5%
5
  41.7%
13
  52.0%
Male
5
  38.5%
7
  58.3%
12
  48.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 12 participants 25 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
13
 100.0%
12
 100.0%
25
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram
Number Analyzed 13 participants 12 participants 25 participants
62.8  (13.69) 64.0  (9.11) 63.4  (11.49)
1.Primary Outcome
Title Antiviral Efficacy is Measured by the Proportion of Subjects With HCV RNA< LLOQ (Lower Limit of Quantification), TD (Target Detected) or TND (Target Not Detected) at 12 Weeks After the End of Treatment.
Hide Description Antiviral efficacy is measured by the proportion of subjects with HCV RNA< LLOQ (lower limit of quantification), TD (target detected) or TND (target not detected) at 12 weeks after the end of treatment (SVR12) in the Full Analysis Set (FAS) population, which include subjects with genotype 1b HCV infection who were enrolled and received at least one dose of study drugs.
Time Frame 12 weeks after the end of treatment (SVR12), after 12 to 24 weeks treatments
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) population includes subjects with genotype 1b HCV infection who were enrolled and received at least one dose of study drugs.
Arm/Group Title Group I Group II
Hide Arm/Group Description:
200 mg TG-2349 (2 capsules) + Interferon or Peg-interferon + Ribavirin
400 mg TG-2349 (4 capsules) + Interferon or Peg-interferon + Ribavirin
Overall Number of Participants Analyzed 13 12
Measure Type: Count of Participants
Unit of Measure: Participants
11
  84.6%
10
  83.3%
2.Secondary Outcome
Title Proportion of Subjects Achieving Sustained Viral Response at 4, 8, and 24 Weeks After the End of Treatment (SVR4, SVR8, and SVR24)
Hide Description [Not Specified]
Time Frame 4, 8, 24 weeks after the end of treatment (SVR4, 8, 24), after 12 to 24 weeks treatments
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) population includes subjects with genotype 1b HCV infection who were enrolled and received at least one dose of study drugs.
Arm/Group Title Group I Group II
Hide Arm/Group Description:
200 mg TG-2349 (2 capsules) + Interferon or Peg-interferon + Ribavirin
400 mg TG-2349 (4 capsules) + Interferon or Peg-interferon + Ribavirin
Overall Number of Participants Analyzed 13 12
Measure Type: Count of Participants
Unit of Measure: Participants
SVR4
12
  92.3%
10
  83.3%
SVR8
11
  84.6%
10
  83.3%
SVR24
11
  84.6%
10
  83.3%
3.Secondary Outcome
Title Proportion of Subjects Achieving HCV RNA < Lower Limit of Quantification, Target Detected or Target Not Detected (< LLOQ, TD or TND)
Hide Description [Not Specified]
Time Frame The whole treatment period, 12 to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) population includes subjects with genotype 1b HCV infection who were enrolled and received at least one dose of study drugs. Missing data were excluded in the dominator of on-treatment visits.
Arm/Group Title Group I Group II
Hide Arm/Group Description:
200 mg TG-2349 (2 capsules) + Interferon or Peg-interferon + Ribavirin
400 mg TG-2349 (4 capsules) + Interferon or Peg-interferon + Ribavirin
Overall Number of Participants Analyzed 13 12
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 13 participants 12 participants
0
   0.0%
0
   0.0%
Day 4 Number Analyzed 13 participants 12 participants
1
   7.7%
0
   0.0%
Week 1 Number Analyzed 13 participants 12 participants
3
  23.1%
4
  33.3%
Day 10 Number Analyzed 13 participants 12 participants
6
  46.2%
8
  66.7%
Week 2 Number Analyzed 13 participants 12 participants
9
  69.2%
10
  83.3%
Week 3 Number Analyzed 13 participants 12 participants
11
  84.6%
10
  83.3%
Week 4 Number Analyzed 12 participants 12 participants
12
 100.0%
11
  91.7%
Week 6 Number Analyzed 11 participants 11 participants
11
 100.0%
11
 100.0%
Week 8 Number Analyzed 11 participants 11 participants
11
 100.0%
11
 100.0%
Week 10 Number Analyzed 11 participants 11 participants
11
 100.0%
11
 100.0%
Week 12 Number Analyzed 11 participants 11 participants
11
 100.0%
11
 100.0%
4.Secondary Outcome
Title Proportion of Subjects Achieving HCV RNA < LLOQ, TND
Hide Description [Not Specified]
Time Frame Treatment period (12 to 24 weeks) and after the end of treatment (12 to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) population includes subjects with genotype 1b HCV infection who were enrolled and received at least one dose of study drugs. Missing data were excluded in the dominator of on-treatment visits, while imputation was performed at post-treatment visits and the dominator for post-treatment visits was the total population.
Arm/Group Title Group I Group II
Hide Arm/Group Description:
200 mg TG-2349 (2 capsules) + Interferon or Peg-interferon + Ribavirin
400 mg TG-2349 (4 capsules) + Interferon or Peg-interferon + Ribavirin
Overall Number of Participants Analyzed 13 12
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 13 participants 12 participants
0
   0.0%
0
   0.0%
Day 4 Number Analyzed 13 participants 12 participants
0
   0.0%
0
   0.0%
Week 1 Number Analyzed 13 participants 12 participants
1
   7.7%
1
   8.3%
Day 10 Number Analyzed 13 participants 12 participants
0
   0.0%
3
  25.0%
Week 2 Number Analyzed 13 participants 12 participants
2
  15.4%
4
  33.3%
Week 3 Number Analyzed 13 participants 12 participants
4
  30.8%
9
  75.0%
Week 4 Number Analyzed 12 participants 12 participants
6
  50.0%
9
  75.0%
Week 6 Number Analyzed 11 participants 11 participants
7
  63.6%
10
  90.9%
Week 8 Number Analyzed 11 participants 11 participants
11
 100.0%
10
  90.9%
Week 10 Number Analyzed 11 participants 11 participants
9
  81.8%
11
 100.0%
Week 12 Number Analyzed 11 participants 11 participants
11
 100.0%
10
  90.9%
Post-Treatment Week 4 Number Analyzed 13 participants 12 participants
12
  92.3%
10
  83.3%
Post-Treatment Week 8 Number Analyzed 13 participants 12 participants
11
  84.6%
10
  83.3%
Post-Treatment Week 12 Number Analyzed 13 participants 12 participants
11
  84.6%
9
  75.0%
Post-Treatment Week 24 Number Analyzed 13 participants 12 participants
10
  76.9%
10
  83.3%
5.Secondary Outcome
Title Mean Absolute Values in HCV RNA (log10 IU/mL)
Hide Description [Not Specified]
Time Frame Treatment period (12 to 24 weeks) and after the end of treatment (12 to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) population includes subjects with genotype 1b HCV infection who were enrolled and received at least one dose of study drugs.
Arm/Group Title Group I Group II
Hide Arm/Group Description:
200 mg TG-2349 (2 capsules) + Interferon or Peg-interferon + Ribavirin
400 mg TG-2349 (4 capsules) + Interferon or Peg-interferon + Ribavirin
Overall Number of Participants Analyzed 13 12
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
Baseline 5.8  (0.83) 5.9  (0.66)
Day 4 1.9  (0.40) 2.0  (0.74)
Week 1 1.4  (0.52) 1.4  (0.54)
Day 10 1.2  (0.19) 1.1  (0.83)
Week 2 1.0  (0.48) 1.0  (0.72)
Week 3 0.7  (0.51) 0.4  (0.78)
Week 4 0.5  (0.54) 0.4  (0.71)
Week 6 0.4  (0.53) 0.1  (0.31)
Week 8 0.0  (0.00) 0.1  (0.31)
Week 10 0.2  (0.42) 0.0  (0.00)
Week 12 0.0  (0.00) 0.1  (0.31)
Post-Treatment Week 4 0.0  (0.00) 0.8  (1.79)
Post-Treatment Week 8 0.2  (0.57) 0.9  (2.13)
Post-Treatment Week 12 0.5  (1.86) 1.0  (2.22)
Post-Treatment Week 24 0.1  (0.31) 0.0  (0.00)
6.Secondary Outcome
Title Proportion of Subjects Experiencing Virologic Failure During Treatment and Viral Relapse After the End of Treatment.
Hide Description [Not Specified]
Time Frame Treatment period (12 to 24 weeks) and after the end of treatment (12 to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) population includes subjects with genotype 1b HCV infection who were enrolled and received at least one dose of study drugs.
Arm/Group Title Group I Group II
Hide Arm/Group Description:
200 mg TG-2349 (2 capsules) + Interferon or Peg-interferon + Ribavirin
400 mg TG-2349 (4 capsules) + Interferon or Peg-interferon + Ribavirin
Overall Number of Participants Analyzed 13 12
Measure Type: Count of Participants
Unit of Measure: Participants
Virologic failure
1
   7.7%
2
  16.7%
On-Treatment failure
0
   0.0%
1
   8.3%
Post-Treatment relapse
1
   7.7%
1
   8.3%
7.Secondary Outcome
Title Proportion of Subjects With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal Limit of ALT at Final Treatment Visit.
Hide Description [Not Specified]
Time Frame From baseline (day 1) to the final treatment visit (week 12 or week 24)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) population includes subjects with genotype 1b HCV infection who were enrolled and received at least one dose of study drugs.
Arm/Group Title Group I Group II
Hide Arm/Group Description:
200 mg TG-2349 (2 capsules) + Interferon or Peg-interferon + Ribavirin
400 mg TG-2349 (4 capsules) + Interferon or Peg-interferon + Ribavirin
Overall Number of Participants Analyzed 13 12
Measure Type: Count of Participants
Unit of Measure: Participants
ALT > ULN at baseline Number Analyzed 13 participants 12 participants
7
  53.8%
7
  58.3%
ALT normalization Number Analyzed 7 participants 7 participants
2
  28.6%
5
  71.4%
8.Secondary Outcome
Title Change From Baseline in HCV RNA (log10 IU/mL)
Hide Description [Not Specified]
Time Frame Treatment period (12 to 24 weeks) and after the end of treatment (12 to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) population includes subjects with genotype 1b HCV infection who were enrolled and received at least one dose of study drugs.
Arm/Group Title Group I Group II
Hide Arm/Group Description:
200 mg TG-2349 (2 capsules) + Interferon or Peg-interferon + Ribavirin
400 mg TG-2349 (4 capsules) + Interferon or Peg-interferon + Ribavirin
Overall Number of Participants Analyzed 13 12
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
Day 4 -3.8  (0.51) -3.9  (0.55)
Week 1 -4.4  (0.50) -4.5  (0.56)
Day 10 -4.6  (0.75) -4.8  (0.78)
Week 2 -4.8  (0.91) -4.9  (1.01)
Week 3 -5.0  (1.03) -5.5  (0.96)
Week 4 -5.2  (0.79) -5.5  (0.73)
Week 6 -5.4  (0.86) -5.7  (0.65)
Week 8 -5.8  (0.90) -5.7  (0.70)
Week 10 -5.6  (0.86) -5.8  (0.67)
Week 12 -5.8  (0.90) -5.7  (0.68)
Post-Treatment Week 4 -5.8  (0.86) -5.1  (1.72)
Post-Treatment Week 8 -5.6  (0.88) -5.0  (2.05)
Post-Treatment Week 12 -5.2  (1.81) -4.8  (2.10)
Post-Treatment Week 24 -5.6  (0.83) -5.8  (0.70)
Time Frame Adverse event that occurred after the first dose of study drugs and no later than the date subject completed/withdrawed from the study will be collected and analyzed.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group I Group II
Hide Arm/Group Description 200 mg TG-2349 (2 capsules) + Interferon or Peg-interferon + Ribavirin 400 mg TG-2349 (4 capsules) + Interferon or Peg-interferon + Ribavirin
All-Cause Mortality
Group I Group II
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)      0/12 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Group I Group II
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/13 (15.38%)      2/12 (16.67%)    
Blood and lymphatic system disorders     
Neutropenia   1/13 (7.69%)  1 0/12 (0.00%)  0
Infections and infestations     
Cellulitis   1/13 (7.69%)  1 0/12 (0.00%)  0
Injury, poisoning and procedural complications     
Lower limb fracture   0/13 (0.00%)  0 1/12 (8.33%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder cancer   0/13 (0.00%)  0 1/12 (8.33%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group I Group II
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/13 (100.00%)      12/12 (100.00%)    
Blood and lymphatic system disorders     
Anaemia   5/13 (38.46%)  5 6/12 (50.00%)  7
Neutropenia   6/13 (46.15%)  7 3/12 (25.00%)  3
Leukopenia   4/13 (30.77%)  6 2/12 (16.67%)  3
Ear and labyrinth disorders     
Vertigo   1/13 (7.69%)  1 0/12 (0.00%)  0
Endocrine disorders     
Hyperthyroidism   0/13 (0.00%)  0 1/12 (8.33%)  1
Eye disorders     
Dry eye   1/13 (7.69%)  1 1/12 (8.33%)  1
Gastrointestinal disorders     
Mouth ulceration   3/13 (23.08%)  3 3/12 (25.00%)  4
Nausea   3/13 (23.08%)  4 1/12 (8.33%)  1
Abdominal distension   1/13 (7.69%)  1 1/12 (8.33%)  1
Diarrhoea   1/13 (7.69%)  1 1/12 (8.33%)  1
Dry mouth   1/13 (7.69%)  1 1/12 (8.33%)  1
Faeces soft   1/13 (7.69%)  1 0/12 (0.00%)  0
Abdominal pain   1/13 (7.69%)  1 0/12 (0.00%)  0
Abdominal pain upper   1/13 (7.69%)  1 0/12 (0.00%)  0
Toothache   1/13 (7.69%)  1 0/12 (0.00%)  0
Vomiting   1/13 (7.69%)  1 0/12 (0.00%)  0
General disorders     
Pain   5/13 (38.46%)  5 5/12 (41.67%)  6
Pyrexia   2/13 (15.38%)  2 4/12 (33.33%)  5
Chest discomfort   2/13 (15.38%)  2 1/12 (8.33%)  1
Fatigue   1/13 (7.69%)  1 2/12 (16.67%)  2
Chest pain   1/13 (7.69%)  1 1/12 (8.33%)  1
Feeling cold   1/13 (7.69%)  2 1/12 (8.33%)  1
Asthenia   1/13 (7.69%)  1 0/12 (0.00%)  0
Injection site erythema   0/13 (0.00%)  0 1/12 (8.33%)  1
Injection site rash   1/13 (7.69%)  1 0/12 (0.00%)  0
Local swelling   1/13 (7.69%)  2 0/12 (0.00%)  0
Malaise   0/13 (0.00%)  0 1/12 (8.33%)  1
Thirst   1/13 (7.69%)  1 0/12 (0.00%)  0
Infections and infestations     
Cellulitis   0/13 (0.00%)  0 1/12 (8.33%)  1
Upper respiratory tract infection   1/13 (7.69%)  1 1/12 (8.33%)  1
Folliculitis   1/13 (7.69%)  1 0/12 (0.00%)  0
Gingivitis   0/13 (0.00%)  0 1/12 (8.33%)  1
Infected dermal cyst   0/13 (0.00%)  0 1/12 (8.33%)  1
Nasopharyngitis   1/13 (7.69%)  1 0/12 (0.00%)  0
Otitis media   0/13 (0.00%)  0 1/12 (8.33%)  1
Pyuria   1/13 (7.69%)  1 0/12 (0.00%)  0
Tonsillitis   1/13 (7.69%)  1 0/12 (0.00%)  0
Injury, poisoning and procedural complications     
Contusion   1/13 (7.69%)  1 0/12 (0.00%)  0
Limb injury   0/13 (0.00%)  0 1/12 (8.33%)  1
Road traffic accident   1/13 (7.69%)  1 0/12 (0.00%)  0
Wound   1/13 (7.69%)  1 0/12 (0.00%)  0
Investigations     
Blood bilirubin increased   1/13 (7.69%)  1 1/12 (8.33%)  1
Alanine aminotransferase increased   1/13 (7.69%)  1 0/12 (0.00%)  0
Aspartate aminotransferase increased   1/13 (7.69%)  1 0/12 (0.00%)  0
Blood creatine phosphokinase increased   1/13 (7.69%)  1 0/12 (0.00%)  0
Gamma-glutamyltransferase increased   1/13 (7.69%)  1 0/12 (0.00%)  0
Platelet count decreased   0/13 (0.00%)  0 1/12 (8.33%)  1
Metabolism and nutrition disorders     
Decreased appetite   3/13 (23.08%)  3 3/12 (25.00%)  3
Musculoskeletal and connective tissue disorders   2/13 (15.38%)  2 1/12 (8.33%)  1
Back pain   2/13 (15.38%)  2 0/12 (0.00%)  0
Plantar fasciitis   0/13 (0.00%)  0 1/12 (8.33%)  1
Nervous system disorders     
Dizziness   4/13 (30.77%)  6 4/12 (33.33%)  4
Headache   4/13 (30.77%)  7 3/12 (25.00%)  3
Memory impairment   2/13 (15.38%)  2 1/12 (8.33%)  1
Dysgeusia   0/13 (0.00%)  0 1/12 (8.33%)  1
Psychiatric disorders     
Insomnia   4/13 (30.77%)  4 1/12 (8.33%)  1
Anxiety   1/13 (7.69%)  1 1/12 (8.33%)  2
Attention deficit/hyperactivity disorder   1/13 (7.69%)  1 1/12 (8.33%)  2
Depression   0/13 (0.00%)  0 1/12 (8.33%)  1
Irritability   1/13 (7.69%)  1 0/12 (0.00%)  0
Sleep disorder   0/13 (0.00%)  0 1/12 (8.33%)  1
Respiratory, thoracic and mediastinal disorders     
Cough   2/13 (15.38%)  2 3/12 (25.00%)  3
Dyspnoea   1/13 (7.69%)  1 0/12 (0.00%)  0
Epistaxis   0/13 (0.00%)  0 1/12 (8.33%)  1
Oropharyngeal pain   0/13 (0.00%)  0 1/12 (8.33%)  1
Productive cough   1/13 (7.69%)  1 0/12 (0.00%)  0
Skin and subcutaneous tissue disorders     
Pruritus   4/13 (30.77%)  4 5/12 (41.67%)  6
Alopecia   3/13 (23.08%)  3 2/12 (16.67%)  2
Rash   1/13 (7.69%)  1 2/12 (16.67%)  2
Dry skin   1/13 (7.69%)  1 1/12 (8.33%)  1
Eczema   1/13 (7.69%)  1 0/12 (0.00%)  0
Papule   1/13 (7.69%)  1 0/12 (0.00%)  0
Rash pruritic   1/13 (7.69%)  1 0/12 (0.00%)  0
Seborrhoeic dermatitis   0/13 (0.00%)  0 1/12 (8.33%)  1
Vesicle   0/13 (0.00%)  0 1/12 (8.33%)  1
Vascular disorders     
Hypertension   1/13 (7.69%)  1 0/12 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Li-Wen Chang
Organization: TaiGen Biotechnology Co., Ltd.
Phone: +886-2-8177-7020 ext 1227
EMail: lwchang@taigenbiotech.com
Layout table for additonal information
Responsible Party: TaiGen Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT02340962     History of Changes
Other Study ID Numbers: TG-2349-03
First Submitted: January 8, 2015
First Posted: January 19, 2015
Results First Submitted: September 11, 2018
Results First Posted: October 12, 2018
Last Update Posted: October 12, 2018