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Pegasys® Plus Ribavirin in Hemophilic Patients With Hepatitis C Virus Infection

Information source: Baqiyatallah Medical Sciences University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C; Hemophilia

Intervention: PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin) (Drug); PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Baqiyatallah Medical Sciences University

Official(s) and/or principal investigator(s):
Professor Seyed-Moayed Alavian, Professor, Study Chair, Affiliation: Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Seyyed Mohammad Miri, M.D., Study Director, Affiliation: Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Maryam Keshvari, M.D., Principal Investigator, Affiliation: Iranian blood Transfusion Research Center
Bita Behnava, M.D., Principal Investigator, Affiliation: Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Mohammad Hossein Somi, M.D., Principal Investigator, Affiliation: Research Center for Gastroenterology and Hepatology, Tabriz University of Medical Sciences, Tabriz
Fariborz Mansour-Ghanaei, M.D., Principal Investigator, Affiliation: Gastroenterology and Liver Diseases, Gastrointestinal and Liver Diseases Research Center (GLDRC), Guilan University of Medical Sciences, Rasht, Iran
Pegah Karimi, M.D., Principal Investigator, Affiliation: Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Bashir HajiBeigi, M.D., Principal Investigator, Affiliation: Iranian Blood Transfusion Research Center

Summary

Hemophilic patients are a known high risk groups for acquiring the hepatitis C. The surveillance data from Ministry Of Health in IR. Iran had shown that 60% of them are infected with HCV infection. We are trying the PEGASYS plus Ribavirin in Hemophilic patients with HCV.

Clinical Details

Official title: A Study on PEGASYS (Peginterferon Alfa-2a (40KD)) Plus COPEGUS (Ribavirin) in Iranian Hemophilic Patients With Chronic Hepatitis C Infection

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Early Virologic Response

End of Treatment Response

Sustained Virologic Response

Rapid Virologic Response

Secondary outcome:

Tolerability of drugs for whole therapy period

Biochemical response (ALT)

Laboratory Parameters

Detailed description: The investigators enroll 400 patients into the study. The patients receive PEGASYS (Peginterferon alpha-2a(40 KD)) 180 microgram per week plus COPEGUS (Ribavirin) 800 microgram for Genotype 2 and 3 and 1000 milligram for weight less than 75 kg and 1200 milligram for more than 75 kg. The duration of protocol is depends on genotypes of virus. In genotype 1 and 4, for 48 week and in genotypes 2 and 3 , for 24 weeks. The patients are visited every 4 weeks with biochemistry lab tests. The patients are checked with quantitative HCV RNA on the third months 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. We have omitted the liver biopsy in the patients.

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- HCV RNA positive

- Age older than 12 years

Exclusion Criteria:

- Ongoing pregnancy or breast feeding

- Hx of HCC

- Hx of alcoholic liver disease

- Hx of bleeding from esophageal varices

- Hx of hemochromatosis

- Hx of autoimmune hepatitis

- Hx of Suicidal attempt

- Hx of cerebrovascular dis

- Hx of severe retinopathy

- Hx of severe psoriasis

- Hx of scleroderma

- Hx of metabolic liver disease

- Hx of SLE

Locations and Contacts

Baqiyatallah Research Center for Gastroenterology and Liver Diseases, Tehran 14155-3651, Iran, Islamic Republic of
Additional Information

Related publications:

Iafolla M. [Pegasys: FDA approved Pegasys (peginterferon alfa-2a) for the treatment of hepatitis C]. Sidahora. 2002;(4):8-10. Spanish.

Starting date: March 2007
Last updated: September 16, 2009

Page last updated: August 23, 2015

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