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Clinical Trials/EUCTR2014-000824-12-ES
EUCTR2014-000824-12-ES
Active, not recruiting
Not Applicable

A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Subjects who have Failed Prior Treatment with Pegylated Interferon and Ribavirin (P/R) with Chronic HCV GT1, GT4, GT5, and GT6 Infection

Merck Sharp & Dohme Corp.0 sites400 target enrollmentApril 11, 2014
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ConditionsHepatitis CMedDRA version: 16.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
DrugsRebetol

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hepatitis C
Sponsor
Merck Sharp & Dohme Corp.
Enrollment
400
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 11, 2014
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Be \> or \= to 18 years of age on day of signing informed consent.
  • •2\. HCV RNA (\> or \= to 10,000 IU/mL in peripheral blood) at the time of screening.
  • •3\. Have documented chronic HCV GT1, GT4, GT5 or GT6
  • •4\. Have had a liver biopsy, Fibroscan, or Fibrotest to check for cirrhosis
  • •5\. Have a previous HCV treatment status that is of non\-response, partial response or treatment relapse
  • •6\. For HIV\-1 co\-infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit
  • •7\. For HIV\-1 co\-infection CD4\+ T\-cell count \> 200 cells/mm3 at screening
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

  • •1\. Has evidence of decompensated liver disease
  • •2\. Is coinfected with hepatitis B virus (e.g. HBsAg positive).
  • •3\. Has previous direct acting antiviral treatment.
  • •4\. Has signs of hepatocellular carcinoma or history of malignancy
  • •5\. Is taking or plans to take (a) any HIV therapy, or other medication
  • •not allowed for the study
  • •6\. Have an exclusionary laboratory value

Outcomes

Primary Outcomes

Not specified

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