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Open-Label Safety Study of Telaprevir and Sofosbuvir in Chronic Hepatitis C Genotype 1 (STEADFAST)

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ClinicalTrials.gov Identifier: NCT01994486
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : March 6, 2015
Last Update Posted : April 23, 2018
Sponsor:
Collaborator:
Vertex Pharmaceuticals Incorporated
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C, Chronic
Intervention Drug: Telaprevir and Sofosbuvir
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Telaprevir and Sofosbuvir
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All subjects will receive Telaprevir 1125 mg capsule twice a day with Sofosbuvir 400 mg capsule once daily for 12 weeks.

In addition, sparse PK samples will be collected at week 2 and week 10.

Period Title: Overall Study
Started 20
Completed 20
Not Completed 0
Arm/Group Title Telaprevir and Sofosbuvir
Hide Arm/Group Description

All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks.

Telaprevir and Sofosbuvir: All subjects will have an ECG performed. Then they will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks. In addition, PK samples will be collected at week 2 and week 10.

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
HCV GENOTYPE 1 -NON-CIRRHOTIC ADULTS
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
17
  85.0%
>=65 years
3
  15.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants
51
(20 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
13
  65.0%
Male
7
  35.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
1.Primary Outcome
Title Frequency of Adverse Events Leading to Discontinuation of Both Telaprevir and Sofosbuvir Among Subjects Treated With Telaprevir and Sofosbuvir
Hide Description Study drug adherence and adverse events were collected on all enrolled subjects and graded using the DAIDS scale. Any adverse events leading to discontinuation of both Telaprevir and Sofosbuvir were collected and are hereby reported.
Time Frame 12 weeks-January 3, 2014- April 10, 2014
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Hide Analysis Population Description
Non-cirrhotic Hepatitis C Genotype 1 infected subjects, naive to previous Hepatitis C treatment
Arm/Group Title Telaprevir and Sofosbuvir
Hide Arm/Group Description:
All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily for 12 weeks.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
0
2.Primary Outcome
Title Safety of Telaprevir and Sofosbuvir When Dosed in Combination for 12 Weeks
Hide Description The number of subjects who experienced Grade 3 anemia. Complete blood count was collected at baseline, week 2, week 4, week 8, week 12, week 18, and week 24. Incidence of moderate anemia (Grade 3) observed in the study treatment period.
Time Frame 1/3/2014-4/10/2014
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Telaprevir and Sofosbuvir
Hide Arm/Group Description:

All subjects will receive Telaprevir 1125 mg capsule twice a day with Sofosbuvir 400 mg capsule once daily for 12 weeks.

In addition, sparse PK samples will be collected at week 2 and week 10.

Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
1
3.Secondary Outcome
Title Characterize Steady State of Sofosbuvir Active SOF Metabolite, GS-331007
Hide Description Sparse Pharmokinetic blood samples were collected at Week 2 and Week 10 (prior to daily dose) in patients treated with Telaprevir and Sofosbuvir.
Time Frame 1/17/2014-3/26/2014
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Telaprevir and Sofosbuvir
Hide Arm/Group Description:

All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks.

Telaprevir and Sofosbuvir: All subjects will have an ECG performed. Then they will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks. In addition, PK samples will be collected at week 2 and week 10.

Overall Number of Participants Analyzed 20
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
Pre-Dose Trough Level Metabolite GS-331007 Wk 2 593  (181)
Pre-Dose Trough Level GS-331007 Wk 10 619  (216)
4.Secondary Outcome
Title Proportion of Subjects Who Achieve Undetectable Hepatitis C Virus RNA at 12 Weeks After Completing Study Drug Regimen
Hide Description Plasma HCV RNA levels were assessed using the COBAS TaqMan HCV RNA assay test (v2.0; Roche Diagnostics, Indianapolis, IN, USA; LLOQ=25 IU/mL;limit of detection =15 IU/mL)
Time Frame 6/16/2014-7/2/2014
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Telaprevir and Sofosbuvir
Hide Arm/Group Description:

All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks.

Telaprevir and Sofosbuvir: All subjects will have an ECG performed. Then they will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks. In addition, PK samples will be collected at week 2 and week 10.

Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
19
5.Secondary Outcome
Title Proportion of Subjects With Viral Relapse
Hide Description Defined as Subjects who have undetectable HCV RNA at end of treatment, and confirmed detectable HCV RNA between end of treatment and SVR12 planned assessment time point.
Time Frame 1/3/2014-9/8/2014
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Telaprevir and Sofosbuvir
Hide Arm/Group Description:
All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily for 12 weeks.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
1
6.Other Pre-specified Outcome
Title Number of Subjects With Sustained Virologic Response at 4 Weeks After Completion of Last Dose
Hide Description Subjects who complete assigned treatment and have undetectable HCV RNA at 12 weeks after the last planned dose of study treatment
Time Frame 4/22/2014-5/6/2014
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Telaprevir and Sofosbuvir
Hide Arm/Group Description:

All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks.

Telaprevir and Sofosbuvir: All subjects will have an ECG performed. Then they will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks. In addition, PK samples will be collected at week 2 and week 10.

Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
19
Time Frame 24 weeks
Adverse Event Reporting Description AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
 
Arm/Group Title Telaprevir and Sofosbuvir
Hide Arm/Group Description All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily for 12 weeks.
All-Cause Mortality
Telaprevir and Sofosbuvir
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Telaprevir and Sofosbuvir
Affected / at Risk (%) # Events
Total   1/20 (5.00%)    
Cardiac disorders   
Bradycardia  1  1/20 (5.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Telaprevir and Sofosbuvir
Affected / at Risk (%) # Events
Total   19/20 (95.00%)    
Blood and lymphatic system disorders   
Anaemia  1  1/20 (5.00%)  1
Leukocytosis  1  1/20 (5.00%)  1
Ear and labyrinth disorders   
Tinnitus  1  1/20 (5.00%)  1
Vertigo  1  1/20 (5.00%)  1
Gastrointestinal disorders   
Abdominal bloating  1  1/20 (5.00%)  1
Abdominal cramps  1  1/20 (5.00%)  1
Abdominal pain  1  2/20 (10.00%)  2
Anorectal_symptoms  1  6/20 (30.00%)  6
Constipation  1  4/20 (20.00%)  4
Diarrhea  1  2/20 (10.00%)  2
Hemorrhoids  1  2/20 (10.00%)  2
Increased frequency of bowel movements  1  1/20 (5.00%)  1
Lip swelling  1  1/20 (5.00%)  1
Loose stools  1  1/20 (5.00%)  1
Nausea  1  9/20 (45.00%)  9
Regurgitation  1  1/20 (5.00%)  1
Vomiting  1  3/20 (15.00%)  3
General disorders   
Chills  1  1/20 (5.00%)  1
Fatigue  1  4/20 (20.00%)  4
Gait disturbance  1  1/20 (5.00%)  1
Induration  1  2/20 (10.00%)  3
Irritability  1  2/20 (10.00%)  2
Peripheral edema  1  2/20 (10.00%)  2
Infections and infestations   
Head cold  1  2/20 (10.00%)  3
Sinusitis  1  1/20 (5.00%)  1
Tooth abscess  1  1/20 (5.00%)  1
Upper respiratory infection  1  1/20 (5.00%)  1
Urinary tract infection  1  1/20 (5.00%)  1
Injury, poisoning and procedural complications   
Corneal abrasion  1  1/20 (5.00%)  1
Investigations   
Blood creatinine increased  1  1/20 (5.00%)  1
Metabolism and nutrition disorders   
Anorexia  1  1/20 (5.00%)  1
Hyperkalemia  1  1/20 (5.00%)  1
Hypokalemia  1  1/20 (5.00%)  1
Musculoskeletal and connective tissue disorders   
Herniated disc  1  1/20 (5.00%)  1
Neck pain  1  1/20 (5.00%)  1
Rib pain  1  1/20 (5.00%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Squamous cell carcinoma  1  1/20 (5.00%)  1
Nervous system disorders   
Dizziness  1  1/20 (5.00%)  1
Dysgeusia  1  2/20 (10.00%)  2
Head pressure  1  1/20 (5.00%)  1
Headache  1  6/20 (30.00%)  6
Lightheadedness  1  1/20 (5.00%)  1
Tingling  1  1/20 (5.00%)  1
Psychiatric disorders   
Depression  1  2/20 (10.00%)  2
Hyperactivity  1  1/20 (5.00%)  1
Respiratory, thoracic and mediastinal disorders   
Nasal congestion  1  1/20 (5.00%)  1
Painful respiration  1  1/20 (5.00%)  1
Skin and subcutaneous tissue disorders   
Alopecia  1  3/20 (15.00%)  3
Blister  1  1/20 (5.00%)  1
Pruritus  1  5/20 (25.00%)  5
Rash  1  8/20 (40.00%)  8
Vascular disorders   
Flushing  1  1/20 (5.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Giuseppe (Joseph) Morelli, MD
Organization: UNIVERSITY OF FLORIDA
Phone: 352-273-9467
EMail: GIUSEPPE.MORELLI@MEDICINE.UFL.EDU
Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01994486    
Other Study ID Numbers: 20132125
First Submitted: November 12, 2013
First Posted: November 25, 2013
Results First Submitted: February 20, 2015
Results First Posted: March 6, 2015
Last Update Posted: April 23, 2018