Open-Label Safety Study of Telaprevir and Sofosbuvir in Chronic Hepatitis C Genotype 1 (STEADFAST)
|ClinicalTrials.gov Identifier: NCT01994486|
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : March 6, 2015
Last Update Posted : April 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C, Chronic||Drug: Telaprevir and Sofosbuvir||Phase 2|
Starting on Day 1 and for up to 12 weeks, you will receive Telaprevir (TVR) and Sofosbuvir (SOF).
You will take one (1) 400 mg tablet of SOF and 3 tablets (1125 mg each) of TVR. You should take these together by mouth every morning. You will take another 3 tablets (1125 mg each) of TVR by mouth 12 hours after you take your morning dose.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-Label Study to Evaluate the Safety and Tolerability of Telaprevir in Combination With Sofosbuvir in Treatment Naive Subjects Chronically Infected With Hepatitis C Virus Genotype 1|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||September 2014|
Experimental: Telaprevir and Sofosbuvir
All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks.
Drug: Telaprevir and Sofosbuvir
All subjects will have time to read and discuss IRB approved consent form prior to any study procedures. Following proper consenting, subjects will undergo physical exam including ECG and bloodwork prior to baseline visit. Subjects will return for research visits (vitals, collection of AEs, bloodwork, drug accountability) on Day 3, Weeks 1, 2, 3, 4, 6, 8, 10 and 12 of treatment and 4, 12, and 24 weeks after end of treatment. PK samples will be collected at week 2 and week 10.
- Frequency of Adverse Events Leading to Discontinuation of Both Telaprevir and Sofosbuvir Among Subjects Treated With Telaprevir and Sofosbuvir [ Time Frame: 12 weeks-January 3, 2014- April 10, 2014 ]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.
- Safety of Telaprevir and Sofosbuvir When Dosed in Combination for 12 Weeks [ Time Frame: 1/3/2014-4/10/2014 ]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.
- Characterize Steady State of Sofosbuvir Active SOF Metabolite, GS-331007 [ Time Frame: 1/17/2014-3/26/2014 ]Sparse Pharmokinetic blood samples were collected at Week 2 and Week 10 (prior to daily dose) in patients treated with Telaprevir and Sofosbuvir.
- Proportion of Subjects Who Achieve Undetectable Hepatitis C Virus RNA at 12 Weeks After Completing Study Drug Regimen [ Time Frame: 6/16/2014-7/2/2014 ]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)
- Proportion of Subjects With Viral Relapse [ Time Frame: 1/3/2014-9/8/2014 ]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.
- Number of Subjects With Sustained Virologic Response at 4 Weeks After Completion of Last Dose [ Time Frame: 4/22/2014-5/6/2014 ]Subjects who complete assigned treatment and have undetectable HCV RNA at 12 weeks after the last planned dose of study treatment
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994486
|United States, Florida|
|UF Hepatology Research at CTRB|
|Gainesville, Florida, United States, 32610|
|Study Director:||DAVID R NELSON, MD||University of Florida|