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Completed

NCT Number: NCT04382339

Sofosbuvir/Pegylated-interferon Plus Ribavirin With HCV Genotype 4

This study aims to assess the efficacy and safety of sofosbuvir (SOF) with pegylated interferon (PegINF)/ribavirin (RBV) for chronic HCV GT4 participants

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Key information

Conditions

Hepatitis C Virus Infection Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

Between March 2015 and November 2015, 99 participants (59 naïve and 40 experienced) infected with HCV GT4 were enrolled in the study. Eligible participants received daily oral 400 mg SOF ( (Sovaldi, Gilead Sciences, Inc., USA), RBV (Copegus, Roche, Europe) based on body weight: < 75 kg, 1000 mg; ≥75 kg, 1200 mg), the dose modified according to participants tolerability, plus 180 μg PegINFα-2 once weekly for 12 weeks.

Experienced participants included participants with a prior relapse or a null response to PegINF/RBV therapy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

The study population consisted of treatment-naïve and treatment-experienced adults patients aged 20-65 with HCV RNA level > 10,000 IU/ml.

Experienced participants included those with a prior relapse or a null response to PegINF/RBV therapy.

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Exclusion criteria

Participants with one or more of

  • HCV coinfected with hepatitis B virus (HBV)
  • human immunodeficiency virus (HIV)
  • had any liver disease other than chronic HCV GT4 infection.
  • had a history of liver decompensation
  • serum a-fetoprotein (AFP) > 100 ng/ml
  • evidence of hepatocellular carcinoma
  • major severe illness such as respiratory, renal, heart failure or autoimmune disease
  • non-compliance with treatment.

Treatment and study plan

SOF/RBV/PegINFα-2

Drug

SOF: block the hepatitis C NS5B protein. RBV: a nucleoside inhibitor PegINFα-2: chemically modified form of the standard interferon that treats hepatitis C

Primary outcomes

  1. Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm SVR12

    Time frame: 12 weeks after last dose

    SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) < 15 IU/m 12 weeks after the last dose of drugs.

  2. Number of Participants With Adverse Events in Each Treatment Arm

    Time frame: Screening until 30 days after last dose

    An adverse event (AE) is defined as any untoward medical occurrence in a participant or i clinical investigation after administering a pharmaceutical drugs serious adverse event (SAE) is an event that results in death, life-threatening, requires hospitalization, or significant disability/incapacity

Secondary outcomes

  1. Percentage of Participants With Viral relapse

    Time frame: 12 weeks after last dose

    Viral relapse was HCV RNA undetectable at EOT, but detectable HCV RNA > 15 IU/ml levels 12 weeks after planned EOT.

  2. Percentage of Participants With On-treatment Virologic Failure

    Time frame: up tp 24 weeks

    On-treatment virologic failure was defined as quantifiable HCV RNA throughout the entire treatment period with HCV RNA greater than 15 IU/ml

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

Effectiveness of Sofosbuvir/Pegylated-interferon Plus Ribavirin in Treatment of Hepatitis C Virus Genotype 4 Patients

Acronym: HCV

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 11, 2020
Registry last updated
May 11, 2020

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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