Status:
UNKNOWN
Peginterferon Alfa-2a, Ribavirin, Amantadine/Placebo in Hepatitis C Virus (HCV)-Genotype-1-Infection (PRAMA)
Lead Sponsor:
University Hospital, Saarland
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
This was a randomized, multi-center, partially placebo-controlled Phase IV study to compare the efficacy and tolerability of a 48-week combined therapy with pegylated interferon alpha-2a, ribavirin an...
Detailed Description
Primary Objective: * Proof that a triple-therapy (peginterferon alfa-2a, ribavirin and amantadine sulphate) dispensed over a period of 50 weeks, improves the permanent virological efficacy by more th...
Eligibility Criteria
Inclusion
- Female and male subjects over 18 years of age and below 70 years of age
- Serological indication of chronic hepatitis C infection with positive anti-HCV test and serum HCV-RNA quantification \>600 IE/ml by means of quantitative proof methods, e.g. Roche AmplicorTM HCV Monitor test, v.2.0.
- Untreated patients with HCV-induced chronic infection.
- Indication of a genotype HCV-1 on the basis of the reverse hybridizing assay Inno LiPA from Bayer Versant (Innogenetics).
- Increased GPT serum level on at least one determination date within the 56-day screening phase prior to start of administration of study medication.
- Histological identification of inflammatory activity in the liver, with or without an indication of compensated cirrhosis, during the 24 months prior to start of the study.
- Compensated liver disease (Child-Pugh Grade A).
- Negative urine or serum pregnancy test in fertile female subjects within 24 hours before taking the first dose of study medication.
- During the administration of study medication and for 24 weeks after the treatment has stopped, patients must apply two approved contraception methods, one of which must have a barrier effect on the male, e.g. condom.
- If one or more of the above inclusion criteria are not fulfilled, the patient is excluded from the study!
Exclusion
- Any known sensitive reaction to interferon, ribavirin or amantadine sulphate.
- Pregnant or breast-feeding women and fertile women who do not practice contraception.
- Male partners of pregnant women.
- Previous treatment with interferon and/or ribavirin.
- Treatment with systemic anti-neoplastic or immunomodulatory medication (supraphysiologic doses of steroids or radiation included) within the last 6 months prior to the study and throughout the whole study.
- Immunosuppressed/immunocompromised patients.
- Participation in a clinical study within the last three months.
- Infection with HCV genotype-2, -3, -4, -5 or -6.
- Positive indication of HBsAg, HIV antibodies in the screening phase.
- Non-hepatitis C virus-induced chronic hepatitis (e.g. hematochromatosis, autoimmune hepatitis, metabolic or alcoholic liver disease).
- Decompensated liver cirrhosis or liver disease; Child-Pugh Grade B or C; or threshold compensated liver disease.
- Signs of a hepatocellular carcinoma within 2 months before the randomization, coupled with existing or developing cirrhosis.
- History of oesophagus varices haemorrhage.
- Hemoglobin \<12 g/dl in female subjects and \<13 g/dl in male subjects in the screening phase.
- Subjects with a higher risk of anemia (e.g. thalassemia, spherocytosis, history of gastrointestinal bleeding) or subjects for whom anemia could be a highly potential medical risk.
- Neutropenia \<1500 /µl or thrombocytopenia \<90,000 /µl diagnosed in the screening phase.
- Serum creatinine \>1.5 mg/dl in the screening phase.
- History of severe psychiatric diseases, especially severe depression, whereby severe psychiatric disease is defined as any anti-depressive or anti-psychotic therapy of at least 3 months in the history, or any indication of suicidal inclination or hospitalization caused by a psychiatric disease.
- Epilepsy.
- Autoimmune disease (e.g. inflammatory intestinal diseases, idiopathic thrombocytopenic purpura, lupus erythematosus sclerodermia, severe psoriasis, rheumatoid arthritis, etc.).
- History of thyroid disease, poorly controlled by prescribed medications
- Chronic pulmonary disease with functional restriction.
- History of severe cardiac disease, e.g. cardiac insufficiency New York Heart Association (NYHA) class III or IV; myocardial infarction within the last 6 months; ventricular tachyarrhythmia requiring treatment; unstable angina pectoris; cerebrovascular circulation disorders; or other significant cardiovascular diseases.
- Patients with pacemakers.
- Cardiomyopathy and myocarditis
- Atrioventricular (AV)-block Grade II and III.
- Previously known bradycardia rating under 55 strokes/minute
- Known, lengthy QT-interval (QTc as per Bazett \> 420 ms) or recognizable U waves or hereditary QT-syndrome in the family history.
- History of a severe ventricular arrythmia including Torsade de pointes.
- Simultaneous therapy with budipine or other QT-extending medication such as:
- Certain antiarrhythmias of class IA (e.g. quinidine, disopyramide, procainamide) and class III (such as amiodarone, sotalol);
- Certain antipsychotics (e.g. thioridazine, chlorpromazine, haloperidol, pimozide);
- Certain tri- and tetracyclic anti-depressive medications (e.g. amitriptyline);
- Certain antihistaminic medications (e.g. astemizol, terfenadin);
- Certain macrolide antibiotics (e.g. erythromycin, clarithromycin);
- Certain gyrase inhibitors (e.g. sparfloxacin);
- Azole-antimycotics and other medications such as halofantrine, cotrimoxazol, pentamidine, cisapride or bepridil;
- Simultaneous treatment with Memantine.
- Morbus Parkinson.
- History of major organ transplantations, with the exception of cornea transplantation.
- Cancer or any other disease, which, in the opinion of the investigator, is an exclusion criterion for the study.
- Evidence of severe retinopathy (e.g. cytomegalovirus \[CMV\] retinitis or macular degeneration).
- Patients with narrow-angle glaucoma.
- Active drug abuse (excessive alcohol consumption included) within the last year prior to study (with the exception of a prescribed substitute).
- Patients with state of agitation or confusion
- Patients with a history of acute brain syndrome or exogenous psychosis
- Patients are already enrolled in the study.
- Prostate hypertrophy
- Simultaneous administering of diuretics of combination type triamterene/hydrochlorothiazide.
- Unwillingness or incapability to give written consent after receiving medical information; doubts about the proper protection of patient data; and general reluctance to take part in the study and to adhere to the study terms.
- If one or more of these exclusion criteria is fulfilled, the patient shall be excluded from the study!
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT00127777
Start Date
July 1 2002
End Date
December 1 2006
Last Update
August 25 2005
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