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Trial record 82 of 382 for:    IFNA2 AND RBV AND genotype

Study to Assess the Efficacy of 12 Versus 24 Weeks of Extended Treatment in HCV-Genotype 2/3 Patients (OPTEX2/3)

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ClinicalTrials.gov Identifier: NCT00803309
Recruitment Status : Terminated (At the end of the planned recruitment period the expected number of subjects could not be included in the trial.)
First Posted : December 5, 2008
Last Update Posted : August 28, 2017
Sponsor:
Collaborator:
Hannover Medical School
Information provided by (Responsible Party):
HepNet Study House, German Liverfoundation

Brief Summary:

In this study we intend to treat patients with chronic hepatitis C of genotype 2 or 3 having characteristics associated with poor treatment response for additional 12 or 24 weeks beyond the standard treatment of PEG-IFN alpha-2b plus ribavirin.

The objective of this study is to compare the efficacy of a treatment extension of 12 versus 24 weeks in patients with HCV-genotypes 2 and 3 who are treated with 1.5 µg/kg PEG-IFN alpha-2b and 800-1400 mg ribavirin (standard dose) for 24 weeks (standard duration) and who are not HCV-RNA negative (< 15 IU/ml) after 4 weeks of standard treatment but HCV-RNA negative after 16-24 weeks of standard treatment.


Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: pegylated interferon alpha-2b Drug: Ribavirin Drug: pegylated Interferon alpha-2b Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2008
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: A
PegIntron® 1.5 µg/kg once weekly (QW) subcutaneous (sc) plus Rebetol® 800-1400 mg per os divided in 2 daily doses for additional 24 weeks beyond standard treatment with 24 weeks follow-up
Drug: pegylated interferon alpha-2b
1.5 µg/kg once weekly, syringe, 24 weeks
Other Name: PegIntron

Drug: Ribavirin
800-1400 mg per os, daily, tablets, 24 weeks
Other Name: Rebetol

Active Comparator: B
PegIntron® 1.5 µg/kg QW sc plus Rebetol® 800-1400 mg per os divided in 2 daily doses for additional 12 weeks beyond standard treatment with 24 weeks follow-up
Drug: pegylated Interferon alpha-2b
1.5 µg/kg once weekly, syringe, 12 weeks
Other Name: PegIntron

Drug: Ribavirin
800-1400 mg per os, daily, tablets, 12 weeks
Other Name: Rebetol




Primary Outcome Measures :
  1. Reduction of Relapse rate (HCV-RNA positive in serum by a standard HCV-PCR with a detection limit of at least 15 IU/ml) 24 weeks after the end of treatment and thus improvement of sustained virological response rates (SVR) [ Time Frame: 48 weeks (arm A) or 36 weeks (arm B) ]

Secondary Outcome Measures :
  1. Virological response rates (HCV-RNA negative in serum by a standard HCV-PCR with a detection limit of at least 15 IU/ml) at the end of therapy [ Time Frame: 24 weeks (arm A) or 12 weeks (arm B) ]
  2. Biochemical responses as determined by ALT and AST levels at the end of treatment and at the end of follow up. [ Time Frame: Arm A: 24 and 24 weeks, arm B: 12 and 24 weeks ]
  3. Severity and frequency of adverse event [ Time Frame: 48 weeks (arm A) or 36 weeks (arm B) ]
  4. Analysis of quality of life [ Time Frame: 48 weeks (arm A) or 36 weeks (arm B) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and 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
  • Age ≥ 18 years
  • Compensated liver disease (Child-Pugh Grade A clinical classification)
  • 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
  • Ongoing treatment with 1.5 µg/kg Peg-Interferon alpha-2b (PegIntron®) and > 10.6 mg/kg ribavirin (Rebetol®)
  • No rapid virological response (HCV-RNA positive after week 4 of the ongoing therapy)
  • Willingness to give written informed consent and willingness to participate to and to comply with the study protocol

Exclusion Criteria:

  • Women with ongoing pregnancy or breast feeding
  • Male partners of women who are pregnant
  • Positive tests at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, HBeAg, anti-HIV, HIV-RNA
  • 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)
  • History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
  • Patients with liver cirrhosis with a lesion suspicious for hepatic malignancy on the screening
  • Absolute neutrophil count (ANC) <750 cells/mm3 at screening
  • Platelet count <50,000 cells/mm3 at screening
  • Hb <10 g/dl at screening
  • Dose modification of Peg-Interferon alpha-2b (PegIntron®) or ribavirin (Rebetol®) during the first 4 weeks of the ongoing therapy
  • Interferon alpha or ribavirin therapy at any time point before the actual ongoing treatment
  • Less than 80% adherence to treatment of the ongoing treatment until randomization (week 20-22 of ongoing treatment)
  • Serum creatinine level >1.5 times the upper limit of normal at screening
  • History of severe psychiatric disease, especially depression (ICD 10 codes F30-F33). Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time. Patients are excluded if any history of suicidal attempts is evident. If hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease are documented, psychiatric consultation is mandatory. Patients with a mild or moderate psychiatric disease (ICD 10 codes F32.0, F32.1, F33.0, F33.1) are only allowed to be included into the trial if a regular monitoring by a psychiatrist is performed during the trial
  • History of a severe seizure disorder or current anticonvulsant use
  • History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis)
  • History or any other evidence of autoimmune diseases
  • History or other evidence of chronic pulmonary disease associated with functional limitation
  • History of significant cardiac disease that could be worsened by acute anemia (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months prior to treatment with Peg-Interferon/ribavirin therapy, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina)
  • Evidence of thyroid disease that is poorly controlled on prescribed medications
  • Evidence of severe retinopathy (e.g. CMV retinitis, macular degeneration)
  • History of major organ transplantation with an existing functional graft
  • History or other evidence of severe illness, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
  • History of any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study
  • Patients with evidence for tuberculosis
  • Drug abuse within 6 months prior to the first dose of study drug and excessive alcohol consumption. Patients on methadone/polamidone/buprenorphine programs are not excluded
  • Any investigational drug and/or participation in another clinical study prior 6 months to the actual ongoing antiviral treatment
  • Limited contractual capability

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00803309


  Show 49 Study Locations
Sponsors and Collaborators
HepNet Study House, German Liverfoundation
Hannover Medical School
Investigators
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Study Director: Michael P. Manns, Prof. Dr. Hannover Medical School

Additional Information:
Publications of Results:
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Responsible Party: HepNet Study House, German Liverfoundation
ClinicalTrials.gov Identifier: NCT00803309     History of Changes
Other Study ID Numbers: P05498
First Posted: December 5, 2008    Key Record Dates
Last Update Posted: August 28, 2017
Last Verified: August 2017
Keywords provided by HepNet Study House, German Liverfoundation:
Chronic HCV-genotype 2/3
Efficacy of treatment extension
PegIntron
pegylated interferon alpha-2b
Rebetol
ribavirin
Additional relevant MeSH terms:
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Ribavirin
Interferon-alpha
Interferon alpha-2
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Interferons
Peginterferon alfa-2b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs