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Completed

NCT Number: NCT01826981

Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection in Participants With Chronic Genotype 1, 2, 3, or 6 HCV Infection

The purpose of this study is to evaluate the antiviral efficacy, safety, tolerability of combination therapy with sofosbuvir (SOF) containing regimens for the treatment of chronic hepatitis C virus (HCV) infection.

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Auckland Clinical Studies Ltd., Auckland, New Zealand

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic genotype 1, 2, 3, or 6 HCV infection
  • Cirrhosis determination; a liver biopsy may be required
  • Screening laboratory values within defined thresholds
  • Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion criteria

  • Pregnant or nursing female or male with pregnant female partner
  • Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
  • Chronic use of systemic immunosuppressive agents
  • History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol

Treatment and study plan

LDV/SOF

Drug

Ledipasvir/sofosbuvir (LDV/SOF) (90 /400 mg) fixed-dose combination (FDC) tablet administered orally once daily

Other names: Harvoni®, GS-5885/GS-7977

SOF

Drug

SOF 400 mg tablet administered orally once daily

Other names: GS-7977, Sovaldi®

RBV

Drug

Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Peg-IFN

Drug

pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly

Other names: Pegasys®

GS-9669

Drug

GS-9669 500 mg (2 × 250 mg tablet) administered orally once daily

VEL

Drug

Velpatasvir (VEL) tablet(s) administered orally once daily

Other names: GS-5816

Primary outcomes

  1. Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)

    Time frame: Posttreatment Week 12

    SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) at 12 weeks after stopping study treatment.

  2. Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)

    Time frame: Up to 24 weeks plus 30 days

Secondary outcomes

  1. Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment

    Time frame: Weeks 1 and 2

  2. Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment

    Time frame: Weeks 4, 6, and 8

  3. Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment

    Time frame: Week 10

  4. Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment

    Time frame: Week 12

  5. Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment

    Time frame: Weeks 16, 20, and 24

  6. Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)

    Time frame: Posttreatment Weeks 2, 4, 8, and 24

  7. For Cohort 6, Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 16 and 20 Weeks After Discontinuation of Therapy (SVR16 and SVR 20)

    Time frame: Posttreatment Weeks 16 and 20

  8. Percentage of Participants With On-treatment Virologic Failure

    Time frame: Up to Posttreatment Week 24

    On-treatment virologic failure was defined as:

    • Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
    • Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
    • Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)

  9. Percentage of Participants Experiencing Viral Relapse

    Time frame: Up to Posttreatment Week 24

    Viral relapse is defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 9, 2013
Registry last updated
Nov 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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