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The Effects of Adding TCM-700C on the Standard Combination Treatment for Patients With Genotype 1 Hepatitis C Infection (TCM-700C)

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ClinicalTrials.gov Identifier: NCT00556504
Recruitment Status : Completed
First Posted : November 12, 2007
Results First Posted : July 8, 2014
Last Update Posted : August 7, 2014
Sponsor:
Information provided by (Responsible Party):
TCM Biotech International Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Hepatitis C
Interventions Drug: TCM-700C
Drug: Peginterferon alfa-2a
Drug: Ribavirin
Drug: Placebo
Enrollment 84
Recruitment Details recruitment period: 12 Months location: CGMH clinical ceters
Pre-assignment Details  
Arm/Group Title TCM-700C Placebo
Hide Arm/Group Description

TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C

TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.

Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C

Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.

Period Title: Overall Study
Started 42 42
Intend-to Treat Population 42 42
Safety Population 41 42
Completed 34 33
Not Completed 8 9
Arm/Group Title TCM-700C Placebo Total
Hide Arm/Group Description TCM-700C, an add-on drug to conventional treatment of Hepatitis C Placebo with convetional treatment for HCV patients Total of all reporting groups
Overall Number of Baseline Participants 42 42 84
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 42 participants 84 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
42
 100.0%
42
 100.0%
84
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 42 participants 84 participants
48.6  (9.58) 48.74  (11.52) 48.67  (10.53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 42 participants 84 participants
Female
22
  52.4%
15
  35.7%
37
  44.0%
Male
20
  47.6%
27
  64.3%
47
  56.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Taiwan Number Analyzed 42 participants 42 participants 84 participants
42 42 84
Fibrosis score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants 42 participants 84 participants
Fibrosis score 0 0 2 2
Fibrosis score 1 11 21 32
Fibrosis score 2 31 19 50
[1]
Measure Description:

Liver biopsy within 12 months prior to study entry showed liver cirrhosis with METAVIR system fibrosis score

0 No fibrosis

  1. Stellate enlargement of portal tract but without septa formation
  2. Enlargement of portal tract with rare septa formation
1.Primary Outcome
Title Sustained Virologic Response (SVR)
Hide Description

SVR is defined as no detectable HCV RNA in serum of patient at Week 72, which is 24 weeks after the termination of combination drug treatment..

  1. A subject is a sustained responder at a given week, if the subject has negative HCV RNA at that week and all the subsequent weeks through Week 72.
  2. If a patient has a missing value between visits, then the last non-missing HCV RNA is carried forward to fill in the missing value.
  3. If the patient's HCV RNA at last visit, Week 72 is missing or above the limit of detection, then the patient is a non-responder, even if all the previous visits from baseline onwards were undetectable.

Serum HCV RNA will be tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit)

Time Frame 24 weeks after the termination of combinational drug treatment (up to 72 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TCM-700C Placebo
Hide Arm/Group Description:

TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C

TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.

Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C

Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.

Overall Number of Participants Analyzed 42 42
Measure Type: Number
Unit of Measure: Number of participants with SVR
27 29
2.Secondary Outcome
Title Virologic Response
Hide Description

undetectable HCV RNA at the end of combination drug treatment

Serum HCV RNA will be tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit).

Time Frame at the end of combination drug treatment (up to 48 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TCM-700C Placebo
Hide Arm/Group Description:

TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C

TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.

Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C

Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.

Overall Number of Participants Analyzed 42 42
Measure Type: Number
Unit of Measure: participants
34 31
3.Secondary Outcome
Title ALT Response
Hide Description

An ALT response is defined as normalization of ALT at the end of combination drug treatment.

(ALT normalization is defined as ALT level decreases into within the normal range)

Time Frame at the end of combination drug treatment (up to 48 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TCM-700C Placebo
Hide Arm/Group Description:

TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C

TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.

Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C

Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.

Overall Number of Participants Analyzed 42 42
Measure Type: Number
Unit of Measure: participants
32 30
4.Secondary Outcome
Title Sustained ALT Response
Hide Description a sustained ALT response is defined as sustained normalization of ALT 24 weeks after cessation of combination drug treatment.
Time Frame 24 weeks after the termination of combinational drug treatment (up to 72 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TCM-700C Placebo
Hide Arm/Group Description:

TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C

TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.

Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C

Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.

Overall Number of Participants Analyzed 42 42
Measure Type: Number
Unit of Measure: participants
26 27
5.Secondary Outcome
Title Combined ALT and Virologic Response
Hide Description Combined ALT and virologic response at the end of combination drug treatment.
Time Frame at the end of combination drug treatment (up to 48 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TCM-700C Placebo
Hide Arm/Group Description:

TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C

TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.

Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C

Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.

Overall Number of Participants Analyzed 42 42
Measure Type: Number
Unit of Measure: participants
31 29
6.Secondary Outcome
Title Immune Cell Normalization
Hide Description

Normalization of immune cells, CD4, CD8 and NK cells at the end of combination drug treatment

(Immune cell normalization is defined as return of CD4, CD8 and NK cells to normal range)

Time Frame at the end of combination drug treatment (up to 48 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TCM-700C Placebo
Hide Arm/Group Description:

TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C

TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.

Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C

Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.

Overall Number of Participants Analyzed 42 42
Measure Type: Number
Unit of Measure: participants
CD4 31 27
CD8 36 31
NK cells 37 31
7.Secondary Outcome
Title Immune Cell Normalization
Hide Description Normalization of immune cells, CD4, CD8 and NK cells at 24 weeks after cessation of combination drug treatment.
Time Frame 24 weeks after the termination of combinational drug treatment (up to 72 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TCM-700C Placebo
Hide Arm/Group Description:

TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C

TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.

Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C

Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.

Overall Number of Participants Analyzed 42 42
Measure Type: Number
Unit of Measure: participants
CD4 30 25
CD8 34 30
NK cells 36 31
Time Frame 72 weeks
Adverse Event Reporting Description

Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study.

one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.

 
Arm/Group Title TCM-700C (Safety Population) Placebo (Safety Population)
Hide Arm/Group Description TCM-700C, an add-on drug to conventional treatment(PegIFN plus RBV)of Hepatitis C Placebo with convetional treatment(PegIFN plus RBV) for HCV patients
All-Cause Mortality
TCM-700C (Safety Population) Placebo (Safety Population)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
TCM-700C (Safety Population) Placebo (Safety Population)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/41 (21.95%)      6/42 (14.29%)    
Blood and lymphatic system disorders     
Anemia  1  1/41 (2.44%)  1 1/42 (2.38%)  1
Ear and labyrinth disorders     
hearing impairment * 1  1/41 (2.44%)  1 0/42 (0.00%)  0
Endocrine disorders     
Rhinorhea * 1  1/41 (2.44%)  1 1/42 (2.38%)  1
Gastrointestinal disorders     
block stools * 2  0/41 (0.00%)  0 1/42 (2.38%)  1
General disorders     
Fever/pain  2  2/41 (4.88%)  2 2/42 (4.76%)  2
sinusitis * 2  0/41 (0.00%)  0 1/42 (2.38%)  1
lose weight * 1  1/41 (2.44%)  1 0/42 (0.00%)  0
Infections and infestations     
Urinary infection * 2  2/41 (4.88%)  2 1/42 (2.38%)  1
Nervous system disorders     
neuritic depression * 1  1/41 (2.44%)  1 0/42 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.1)
2
Term from vocabulary, Serious
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TCM-700C (Safety Population) Placebo (Safety Population)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   41/41 (100.00%)      40/42 (95.24%)    
Blood and lymphatic system disorders     
Anemia * 1  8/41 (19.51%)  10/42 (23.81%) 
Neutropenia * 1  2/41 (4.88%)  0/42 (0.00%) 
Cardiac disorders     
Palpiations * 1  3/41 (7.32%)  4/42 (9.52%) 
Ear and labyrinth disorders     
Deafness * 1  2/41 (4.88%)  1/42 (2.38%) 
Vertigo * 1  2/41 (4.88%)  0/42 (0.00%) 
Endocrine disorders     
Goitre * 1  2/41 (4.88%)  1/42 (2.38%) 
Hypothyroidism * 1  4/41 (9.76%)  0/42 (0.00%) 
Eye disorders     
Conjunctivities * 1  2/41 (4.88%)  1/42 (2.38%) 
Dry Eye * 1  0/41 (0.00%)  2/42 (4.76%) 
Eye pain * 1  2/41 (4.88%)  2/42 (4.76%) 
Gastrointestinal disorders     
Abdominal discomfort * 1  2/41 (4.88%)  0/42 (0.00%) 
Abdominal distention * 1  2/41 (4.88%)  4/42 (9.52%) 
Abdominal pain * 1  3/41 (7.32%)  4/42 (9.52%) 
Abdominal pain upper * 1  5/41 (12.20%)  6/42 (14.29%) 
Apthous stomatits * 1  2/41 (4.88%)  4/42 (9.52%) 
Diarrhea * 1  5/41 (12.20%)  6/42 (14.29%) 
Dry mouth * 1  3/41 (7.32%)  6/42 (14.29%) 
Hemorrhoids * 1  1/41 (2.44%)  3/42 (7.14%) 
Irritable bowel syndrome * 1  2/41 (4.88%)  5/42 (11.90%) 
Nausea * 1  5/41 (12.20%)  8/42 (19.05%) 
Peptic ulcer * 1  4/41 (9.76%)  1/42 (2.38%) 
Reflux esophagitis * 1  2/41 (4.88%)  0/42 (0.00%) 
General disorders     
Asthenia * 1  2/41 (4.88%)  3/42 (7.14%) 
Chills * 1  5/41 (12.20%)  2/42 (4.76%) 
Malaise * 1  5/41 (12.20%)  8/42 (19.05%) 
Pain * 1  4/41 (9.76%)  4/42 (9.52%) 
Fatigue * 1  9/41 (21.95%)  6/42 (14.29%) 
Injection site erythema * 1  2/41 (4.88%)  2/42 (4.76%) 
Edema peripheral * 1  2/41 (4.88%)  2/42 (4.76%) 
Pyrexia * 1  17/41 (41.46%)  13/42 (30.95%) 
Hepatobiliary disorders     
Gallbladder polyp * 1  2/41 (4.88%)  0/42 (0.00%) 
Hepatic steatosis * 1  4/41 (9.76%)  1/42 (2.38%) 
Infections and infestations     
Influenza * 1  2/41 (4.88%)  0/42 (0.00%) 
Nasopharyngitis * 1  1/41 (2.44%)  3/42 (7.14%) 
Pneumonia * 1  0/41 (0.00%)  2/42 (4.76%) 
Upper respiratory tract infection * 1  4/41 (9.76%)  3/42 (7.14%) 
Urinary tract infection * 1  4/41 (9.76%)  3/42 (7.14%) 
Injury, poisoning and procedural complications     
Fall * 1  2/41 (4.88%)  0/42 (0.00%) 
Investigations     
Blood uric acid increased * 1  0/41 (0.00%)  3/42 (7.14%) 
Hemoglobin decreased * 1  10/41 (24.39%)  9/42 (21.43%) 
Neutrophil count decreased * 1  2/41 (4.88%)  3/42 (7.14%) 
Weight decreased * 1  3/41 (7.32%)  4/42 (9.52%) 
White blood cell count decreased * 1  4/41 (9.76%)  2/42 (4.76%) 
Metabolism and nutrition disorders     
Anorexia * 1  5/41 (12.20%)  6/42 (14.29%) 
Decreased appetite * 1  4/41 (9.76%)  4/42 (9.52%) 
Hyperuricaemi * 1  1/41 (2.44%)  2/42 (4.76%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/41 (2.44%)  4/42 (9.52%) 
Back pain * 1  6/41 (14.63%)  6/42 (14.29%) 
Bone pain * 1  2/41 (4.88%)  1/42 (2.38%) 
Flank pain * 1  0/41 (0.00%)  2/42 (4.76%) 
Myalgia * 1  6/41 (14.63%)  5/42 (11.90%) 
Neck pain * 1  2/41 (4.88%)  2/42 (4.76%) 
Pain in extremity * 1  4/41 (9.76%)  0/42 (0.00%) 
Synovitis * 1  2/41 (4.88%)  0/42 (0.00%) 
Tenosynovitis * 1  2/41 (4.88%)  1/42 (2.38%) 
Nervous system disorders     
Dizziness * 1  11/41 (26.83%)  8/42 (19.05%) 
Headache * 1  11/41 (26.83%)  4/42 (9.52%) 
Hypoesthesia * 1  1/41 (2.44%)  2/42 (4.76%) 
Tremor * 1  0/41 (0.00%)  2/42 (4.76%) 
Psychiatric disorders     
Aggression * 1  2/41 (4.88%)  0/42 (0.00%) 
Anxiety * 1  2/41 (4.88%)  4/42 (9.52%) 
Insomnia * 1  10/41 (24.39%)  8/42 (19.05%) 
Mood altered * 1  2/41 (4.88%)  2/42 (4.76%) 
Renal and urinary disorders     
Dysuria * 1  1/41 (2.44%)  2/42 (4.76%) 
Urinary incontinency * 1  0/41 (0.00%)  2/42 (4.76%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia * 1  0/41 (0.00%)  2/42 (4.76%) 
Respiratory, thoracic and mediastinal disorders     
Bronchitis chronic * 1  2/41 (4.88%)  0/42 (0.00%) 
Cough * 1  11/41 (26.83%)  13/42 (30.95%) 
Dyspnea * 1  8/41 (19.51%)  10/42 (23.81%) 
Nasal congestion * 1  2/41 (4.88%)  0/42 (0.00%) 
Oropharyngeal pain * 1  3/41 (7.32%)  2/42 (4.76%) 
Productive cough * 1  2/41 (4.88%)  6/42 (14.29%) 
Rhinitis allergic * 1  2/41 (4.88%)  2/42 (4.76%) 
Rhinorrhoea * 1  2/41 (4.88%)  0/42 (0.00%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  7/41 (17.07%)  7/42 (16.67%) 
Eczema * 1  0/41 (0.00%)  2/42 (4.76%) 
Pruritus * 1  15/41 (36.59%)  16/42 (38.10%) 
Rash * 1  8/41 (19.51%)  3/42 (7.14%) 
Rash pruritic * 1  2/41 (4.88%)  2/42 (4.76%) 
Skin disorder * 1  4/41 (9.76%)  1/42 (2.38%) 
Urticaria * 1  2/41 (4.88%)  1/42 (2.38%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.1)
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: Dr. Ya-Chun Wang, EVP/CSO
Organization: TCM Biotech International
Phone: 886-2-26581677 ext 733
EMail: yachunwang@tcmbio.com
Layout table for additonal information
Responsible Party: TCM Biotech International Corp.
ClinicalTrials.gov Identifier: NCT00556504    
Other Study ID Numbers: TCM-700-01-04
First Submitted: November 8, 2007
First Posted: November 12, 2007
Results First Submitted: June 5, 2013
Results First Posted: July 8, 2014
Last Update Posted: August 7, 2014