Clinical trial NCT00527540: Effectiveness and Side Effects of Pegylated Interferon Alpha-2a (Pegaferon®) Plus Ribavirin in the Patients With Chronic Hepatitis C
Official title: Effectiveness and Side Effects of Pegylated Interferon Alpha-2a (Pegaferon®) Plus Ribavirin in the Patients With Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C
Lead sponsor: Tehran Hepatitis Center
Sponsor class: OTHER
Collaborators: name: Kermanshah University of Medical Sciences
First posted: 2007-09-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pegylation of interferon prolongs the medication half-life which has resulted in Pegylated Interferon (PEG-IFN) as the new modality for treatment of chronic hepatitis C. We current this clinical trial to assess the efficacy and safety of domestic PEG-IFN alpha-2a (Pegaferon®) in the patients with chronic hepatitis C.

Detailed description: We enroll 50 patients in to the study. The patients receive Pegaferon® 180 micgr per week plus ribavirin 10-15mg/kg per day. The patients are visited every 4 weeks with biochemistry lab tests. They are checked with quantitative HCV PCR on the third month after initiation of the treatment to assess early virologic response and at the end of the study for complete response rate and on the six month after treatment completion for sustained response rate. The patients with undetectable HCV RNA are considered as responders.

Eligibility criteria: Inclusion Criteria:

* HCV RNA: Positive
* Biopsy approved in genotype 1
* Age older than 18 yrs

Exclusion Criteria:

* ongoing pregnancy or breast feeding
* Hx of hemochromatosis
* Hx of metabolic liver dis.
* Hx of HCC
* Hx of autoimmune hepatitis
* Hx of alcoholic liver dis.
* Hx of bleeding from esophageal varices
* ongoing systemic anti-viral or anti-neoplasmic treatment
* Hx of treatment with an anti-depressant medication at therapeutic doses for at least 3 months at any pervious time
* Hx of treatment with an tranquilizer at therapeutic doses for psychosis for at least 3 months at any pervious time
* Hx of hospitalization for psychiatric dis.
* Hx of suicidal attempt
* Hx of IBD
* Hx of SLE
* Hx of scleroderma
* Hx of rheumatoid arthritis
* Hx of ITP
* Hx of autoimmune hemolytic anemia
* Hx of severe psoriasis
* Hx of chronic pulmonary dis. associated with functional limitation
* Hx of MI or unstable angina
* Hx of arrhythmia requiring ongoing treatment
* Hx of functional class III or IV
* Hx of severe seizure dis. or current anti-convulsant use
* Hx of organ transplantation with existing functional graft
* Hx of severe retinopathy
* Hx of Thalassemia
* Hx of spherocytosis
* Hx of cerebrovascular dis.

Primary outcomes:
measure: End of treatment response rate (HCV RNA:Neg)
timeFrame: End of treatment course
Secondary outcomes:
measure: Sustain response rate (HCV RNA:Neg) 6 month after end of treatment
timeFrame: 6 month after end of treatment
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran Hepatitis Center
Study officials:
affiliation: Tehran Hepatitis Center
name: Seyed M Alavian, Prof.
role: STUDY_CHAIR
affiliation: Tehran Hepatitis Center
name: Behzad Hajarizadeh, MD
role: PRINCIPAL_INVESTIGATOR
References: