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Completed

NCT Number: NCT02247401

Coadministration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) With Ribavirin (RBV) in Adults With Genotype 4 (GT4) Hepatitis C Virus (HCV) in Egypt

This study evaluates the efficacy and safety of ABT-450/r/ABT-267 with RBV in treatment-naive and treatment-experienced HCV GT4 subjects without or with compensated cirrhosis.

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Key information

Conditions

HCV Blood-Borne Infections Communicable Diseases Digestive System Diseases Fibrosis Flaviviridae Infections Genotype 4 Hepatitis Hepatitis C Hepatitis C Infection Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

Non-cirrhotic subjects were directly enrolled into Arm A. Cirrhotic subjects were randomized to either Arm B (12 weeks of treatment) or Arm C (24 weeks of treatment).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Chronic hepatitis C, genotype 4-infection (hepatitis C virus [HCV] ribonucleic acid [RNA] level greater than 1,000 IU/mL at Screening)
  • Subjects must meet one of the following:
  • Treatment-naive: Subject has never received antiviral treatment for HCV infection OR
  • Treatment Experienced (Prior null responders, Partial responders or Relapsers to pegylated-interferon [pegIFN]/RBV);
  • Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control
  • In substudy 1, demonstrated absence of liver cirrhosis as confirmed by liver biopsy or Fibroscan
  • In substudy 2, evidence of liver cirrhosis as confirmed by liver biopsy or Fibroscan with Child-Pugh score less than or equal to 6 at Screening and confirmed absence of hepatocellular carcinoma

Exclusion criteria

  • Females who are pregnant or breastfeeding
  • Positive screen for hepatitis B Surface antigen or anti-Human Immunodeficiency virus antibody
  • HCV genotype performed during screening indicating unable to genotype or co-infection with any other HCV genotype
  • abnormal laboratory tests
  • self-reports current drinking more than 2 drinks per day
  • current enrollment in another investigational study
  • previous treatment with a direct acting antiviral agent (DAA) containing regimen
  • In substudy 1, evidence of liver cirrhosis
  • In substudy 2, evidence of current or past Child-Pugh B or C classification and confirmed presence of hepatocellular carcinoma

Treatment and study plan

2 DAA

Drug

ABT-450/r/ABT-267 tablets

RBV

Drug

Ribavirin tablets

Primary outcomes

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

    Time frame: 12 weeks after last dose

    SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (< LLOQ) 12 weeks after the last dose of study drug.

  2. Number of Participants With Adverse Events

    Time frame: Screening until 30 days after last dose

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.

Secondary outcomes

  1. Percentage of Participants With On-treatment Virologic Failure in Each Treatment Arm

    Time frame: Up to 12 or 24 weeks after first dose

    On-treatment virologic failure was defined as quantifiable HCV RNA throughout the entire treatment period with at least 6 weeks of treatment, confirmed HCV RNA greater than the LLOQ after previously having unquantifiable HCV RNA, or a confirmed increase from nadir of at least one log10 in HCV RNA during treatment.

  2. Percentage of Participants With Post-treatment Relapse Within 12 Weeks Following End of Treatment in Each Arm

    Time frame: Up to 12 weeks after first dose

    Post-treatment relapse was defined as defined as confirmed HCV RNA > LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

An Open-Label Study to Evaluate the Safety and Efficacy of the Coadministration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) With Ribavirin (RBV) in Adults With Chronic Hepatitis C Virus Genotype 4 Infection in Egypt

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 25, 2014
Registry last updated
Jul 30, 2021

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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