Comparative Efficacy of Fixed-dose Combination Sofosbuvir + Ledipasvir, 8 vs. 12 Weeks in Chronic Hepatitis C Genotype 6

Phase 4

Completed

• Conditions: PT-NANBH
• Interventions: Drug: 8 weeks SOF/LED; Drug: 12 weeks SOF/LED

• Registration Number: NCT02480166
• Lead Sponsor: Stanford University

Brief Summary

The primary objectives of this study are to describe the efficacy of:

1. 8-week treatment of SOF/LED for treatment-naïve, non-cirrhotic, HCV genotype 6

2. 12-week treatment of SOF/LED for all other HCV-6 populations

Detailed Description

The secondary objective of this study is to describe safety, persistency, and tolerability of SOF/LED in patients with HCV-6.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-17
• Study First Submitted QC: 2015-06-19
• Study First Posted: 2015-06-24
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Results First Submitted: 2017-07-17
• Status Verified: 2017-08
• Results First Submitted QC: 2017-08-21
• Last Update Submitted: 2017-08-21
• Results First Posted: 2017-09-19
• Last Update Posted: 2017-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Male or female, age ≥18 years
2. HCV genotype 6 or indeterminate and later assessed at Screening and confirmed as genotype 6
3. Selected to start on treatment by their treating providers
4. Willing and able to provide informed consent
5. Able to comply with dosing instructions for study drug administration and able to complete the study schedule of assessments
6. Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative pregnancy test on Baseline
7. Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
8. Lactating females must agree to discontinue nursing before the study drug is administered

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Exclusion Criteria

1. Previous recipient of a liver transplant
2. Co-infection with human immunodeficiency virus (HIV) or hepatitis B (HBV)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
8 weeks SOF/LED	8 weeks SOF/LED	Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.
12 weeks SOF/LED	12 weeks SOF/LED	Patients that are either treatment experienced or are cirrhotic will be assigned to 12 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Sustained Virologic Response (SVR) log10 HCV RNA PCR <25 IU/mL 12 Weeks Post-treatment	12 weeks after end of therapy

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced Serious Adverse Events (SAEs) and/or Adverse Events (AEs) From Informed Consent to 12 Weeks Post-treatment.	Day 1 of treatment to 12 weeks post treatment	Adverse events were defined using Common Terminology Criteria for Adverse Events v3.0 (CTCAE)

Trial Locations

Locations (4)

San Jose Gastroenterology; 🇺🇸 San Jose, California, United States

Liver and Digestive Consultants; 🇺🇸 Houston, Texas, United States

Stanford University Medical Center; 🇺🇸 Palo Alto, California, United States

Digestive Health Associates; 🇺🇸 Plano, Texas, United States