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Clinical Trials/EUCTR2010-022867-37-DE
EUCTR2010-022867-37-DE
Active, not recruiting
Not Applicable

A randomized, double-blind, placebo-controlled trial of the efficacy and safety of DEB025/Alisporivir in combination with peg-IFNalpha2a and ribavirin in hepatitis C genotype 1 treatment-naïve - NA

ovartis Pharma Services AG0 sites1,040 target enrollmentMay 9, 2011
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ConditionsChronic Hepatitis C genotype 1 treatment-naïve patientsMedDRA version: 14.1Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
DrugsCopegusPegasys

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Hepatitis C genotype 1 treatment-naïve patients
Sponsor
ovartis Pharma Services AG
Enrollment
1040
Status
Active, not recruiting
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 9, 2011
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\-Chronic hepatitis C viral
  • •\-HCV genotype
  • •\-no previous treatment for hepatitis C infection
  • •\-Serum HCV RNA level \= 1000 IU/ml assessed by quantitative polymerase chain reaction or equivalent at screening, no upper limit.
  • •\-liver evaluation prior to Baseline: liver biopsy within 3 years or Fibroscan within 6 months.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range: 0
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) yes

Exclusion Criteria

  • •Key exclusion criteria are :
  • •\-HCV genotype different from genotype 1 or co\-infection with other HCV genotype.
  • •\-co\-infection with Hepatitis B or HIV
  • •\-Any other cause of relevant liver disease other than HCV
  • •\-Presence or history of hepatic decompensation
  • •\-ALT \= 10 times ULN,
  • •\- more than 1 episode of elevated bilirubin (\>ULN) in past 6 months
  • •Other protocol\-defined inclusion/exclusion criteria may apply

Outcomes

Primary Outcomes

Not specified

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