Global Observational Cohort Study on the Prediction of Unwanted Adverse Effects in Individuals Infected with Chronic Hepatitis C Receiving a Long-Acting Interferon plus Ribavirin

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT138811193307N1

Enrollment

4000

Registered

2010-04-24

Start date

2010-03-21

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic hepatitis C. Chronic viral hepatitis C

Interventions

180 mg percutneous weekly long acting interferon + 10-15 mg/kg /day oral ribavirin.

Treatment - Drugs

180 mg percutneous weekly long acting interferon + 10-15 mg/kg /day oral ribavirin

Eligibility

Sex/Gender

All

Age

13 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult subjects receiving treatment for CHC with a long-acting interferon plus ribavirin according to standard of care and in line with the current summary of product characteristics (SPC) / local labeling and who have no contra-indication to long-acting interferon and ribavirin therapy as per the local label are eligible for observation in this cohort if the following applies: • Adult (according to local legislation) male or female subjects CHC receiving combination therapy with a long-acting interferon plus ribavirin • Quantifiable serum HCV RNA by polymerase-chain reaction (PCR) before initiation of treatment • Subjects with no contra-indications to long-acting interferon and ribavirin therapy as detailed in the label [e.g.: pregnancy; breast-feeding; hypersensitivity to the active substance, to alpha interferons, ribavirin, or to any of the excipients; autoimmune hepatitis; severe hepatic dysfunction or decompensated cirrhosis of the liver; a history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months; hemoglobinopathies (e.g. thalassemia, sickle-cell anemia); initiation of therapy with longacting interferon plus ribavirin is contraindicated in HIV/HCV patients with cirrhosis and a Child-Pugh score =6] • Subjects without end stage renal disease • Subjects without major organ transplantation • Subjects should not receive concomitant therapy with telbivudine (because concomitant peginterferon therapy is contraindicated according to the telbivudine label) • Subjects with HIV/HCV co-infection should not receive concomitant therapy with azidothymidine (AZT=Zidovudin), didanosine (ddl) and stavudine (d4T) (for safety reasons) • Female subjects not pregnant (pregnancy test immediately prior to initiation of combination therapy) or breast-feeding when combination treatment commenced • Male partners of women who are pregnant should not receive ribavirin • All fertile males and females receiving ribavirin must be using two forms of effective contraception during treatment and during the 6 months after treatment end • Written informed consent where local regulations allow or require it within up to 4 weeks after commencing treatment

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Safety related to dose reduction. Timepoint: Every 3 months. Method of measurement: Assessment of laboratory data.	—

Secondary

Measure	Time frame
SVR rate. Timepoint: Every 3 month. Method of measurement: PCR.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehrdad Nooranipour

Baqiyatallah Research Center for Gastroenterology and Liver Diseases

manager@hepmon.ir+98 21 8861 4523

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026