Status:
TERMINATED
Study to Assess the Efficacy of 12 Versus 24 Weeks of Extended Treatment in HCV-Genotype 2/3 Patients
Lead Sponsor:
HepNet Study House, German Liverfoundation
Collaborating Sponsors:
Hannover Medical School
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT00803309
Start Date
November 1 2008
End Date
August 1 2013
Last Update
August 28 2017
Active Locations (49)
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1
Ärztehaus Leipziger Straße
Berlin, Germany, 10117
2
Medizinisches Infektiologiezentrum
Berlin, Germany, 10439
3
Praxis Dr. med. Naumann
Berlin, Germany, 10627
4
Hepatologische Schwerpunktpraxis im bng
Berlin, Germany, 10969