Skip to main content
OpenTrials
Completed

NCT Number: NCT01641640

Sofosbuvir With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection

This study was to assess whether sofosbuvir in combination with ribavirin (RBV) and pegylated interferon alfa 2a (PEG) administered for 12 weeks is safe and effective in patients with hepatitis C virus (HCV) genotypes 1, 4, 5 , or 6 as assessed by the rate of sustained viral response (SVR) 12 weeks after discontinuation of therapy (SVR12).

Completed

Looking for future studies?

Notify Me

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 3

Primary location

Fundacion De Investigacion De Diego, San Juan, PR, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Infection with HCV genotype 1, 4, 5, or 6
  • Cirrhosis determination
  • Subject met the following classifications:
  • Treatment-naive
  • Screening laboratory values within defined thresholds
  • Not treated with any investigational drug or device within 30 days of screening
  • Use of highly effective contraception methods if female of childbearing potential or sexually active male

Exclusion criteria

  • Prior exposure to an direct-acting antiviral targeting the HCV nonstructural protein (NS)5B polymerase
  • Pregnant or nursing female, or male with pregnant female partner
  • Current or prior history of clinical hepatic decompensation
  • History of clinically-significant illness or any other major medical disorder that may have interfered with subject treatment, assessment, or compliance with the protocol
  • Excessive alcohol ingestion or significant drug abuse

Treatment and study plan

Sofosbuvir

Drug

Sofosbuvir 400 mg tablet administered orally once daily

Other names: Sovaldi®, GS-7977, PSI-7977

RBV

Drug

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

Other names: Ribasphere®

PEG

Drug

Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection

Other names: PEGASYS®

Primary outcomes

  1. Percentage of Participants Achieving Sustained Virologic Response (SVR)12

    Time frame: Posttreatment Week 12

    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after cessation of therapy.

  2. Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug

    Time frame: Baseline to Week 12

    The number of participants experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment. Participants discontinuing study drug were permitted to remain on the study for further assessments.

Secondary outcomes

  1. Percentage of Participants Achieving SVR4

    Time frame: Posttreatment Week 4

    SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy

  2. Percentage of Participants Achieving SVR24

    Time frame: Posttreatment Week 24

    SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy

  3. Percentage of Participants With Viral Breakthrough

    Time frame: Baseline to Week 12

    Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values.

  4. Percentage of Participants With Viral Relapse

    Time frame: End of treatment to post-treatment Week 24

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

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of GS-7977 With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection

Acronym: NEUTRINO

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 17, 2012
Registry last updated
May 8, 2014

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.