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Clinical Trials/EUCTR2008-000706-36-DE
EUCTR2008-000706-36-DE
Active, not recruiting
Phase 1

Optimization of treatment for patients with chronic hepatitis C infected with HCV-genotype 2 or 3: 12 vs. 24 weeks of treatment extension for patients without rapid virological response - OPTEX 2/3

Hannover Medical School; Competence Network Viral Hepatitis (Hep-Net)0 sites150 target enrollmentMay 29, 2008
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DrugsPegIntronRebetol

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Hannover Medical School; Competence Network Viral Hepatitis (Hep-Net)
Enrollment
150
Status
Active, not recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 29, 2008
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Hannover Medical School; Competence Network Viral Hepatitis (Hep-Net)

Eligibility Criteria

Inclusion Criteria

  • •1\. Male or female patients with HCV\-genotype 2/3 chronic hepatitis C documented by detectable plasma HCV RNA (\> 15 IU/mL) and positivity of anti\-HCV antibodies
  • •2\. Age \= 18 years
  • •3\. Compensated liver disease (Child\-Pugh Grade A clinical classification)
  • •4\. Negative urine or blood pregnancy test (one of the both; for women of childbearing potential) documented within the 24\-hour period prior to the first dose of study drug. Additionally, all fertile males and females must be using two forms of effective contraception during treatment and during the 7 months after treatment end. This includes using birth control pills (no interaction with investigational drugs), IUDs, condoms, diaphragms, or implants, being surgically sterilized, or being in a post\-menopausal state. At least one contraception method must be of barrier method
  • •5\. Ongoing treatment with 1\.5 µg/kg Peg\-Interferon alpha\-2b (PegIntron®) and \> 10\.6 mg/kg ribavirin (Rebetol®)
  • •6\. No rapid virological response (HCV\-RNA positive after week 4 of the ongoing therapy)
  • •7\. Willingness to give written informed consent and willingness to participate to and to comply with the study protocol
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range: 0
  • •F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

  • •1\. Women with ongoing pregnancy or breast feeding
  • •2\. Male partners of women who are pregnant
  • •3\. Coinfection with HIV or HBV
  • •4\. History or other evidence of a medical condition associated with chronic liver disease other than HCV associated (e.g. hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures)
  • •5\. History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
  • •6\. Patients with liver cirrhosis with a lesion suspicious for hepatic malignancy on the screening
  • •7\. Absolute neutrophil count (ANC) \<750 cells/mm3 at screening
  • •8\. Platelet count \<50,000 cells/mm3 at screening
  • •9\. Hb \<10 g/dl at screening
  • •10\. Dose modification of Peg\-Interferon alpha\-2b (PegIntron®) or ribavirin (Rebetol®) during the first 4 weeks of the ongoing therapy

Outcomes

Primary Outcomes

Not specified

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