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Pegasys® Plus Ribavirin in Thalassemic 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; Thalassemia

Intervention: 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):
Seyed-Moayed Alavian, Professor, Study Chair, Affiliation: Baqiyatallah Research Center for Gastroenterology and Liver Disea
Seyyed Mohammad Miri, M.D., Study Director, Affiliation: Baqiyatallah Research Center for Gastroenterology and Liver Disea
Pegah Karimi, M.D., Principal Investigator, 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

Summary

Antiviral treatment of HCV in thalassemia has raised concerns of ribavirin-induced hemolysis and increased iron loading. Blood Transfusion in Thalassemic patients are a known high risk for acquiring hepatitis C. The investigators are trying the PEGASYS (Peginterferon alpha-2a(40 KD)) plus Ribavirin in Thalassemic patients with HCV.

Clinical Details

Official title: A Study on PEGASYS (Peginterferon Alfa-2a (40KD)) Plus COPEGUS (Ribavirin) in Iranian Thalassemic 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: Patients with Thalassemia receive chronic blood transfusions and have an increased prevalence of chronic Hepatitis C virus (HCV) infection, particularly if transfused before HCV serological testing became available. The investigators enrolled 300 patients into the study. The patients received PEGASYS (Peginterferon alpha-2a(40 KD)) 180 microgram per week plus COPEGUS (Ribavirin) 1000 milligram for weight less than or equal 75 kg and 1200 milligram for more than 75 kg for 48 weeks. Follow up period is 6 months after treatment. The patients are visited every 4 weeks with biochemistry lab tests. The patients are checked with quantitative HCV RNA (Ribonucleic Acid) 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.

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

- History (Hx) of Hepatocellular Carcinoma (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 Systemic Lupus Erythematosus (SLE)

Locations and Contacts

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

Related publications:

Harmatz P, Jonas MM, Kwiatkowski JL, Wright EC, Fischer R, Vichinsky E, Giardina PJ, Neufeld EJ, Porter J, Olivieri N; Thalassemia Clinical Research Network. Safety and efficacy of pegylated interferon alpha-2a and ribavirin for the treatment of hepatitis C in patients with thalassemia. Haematologica. 2008 Aug;93(8):1247-51. doi: 10.3324/haematol.12352. Epub 2008 Jun 12.

Starting date: May 2007
Last updated: August 30, 2010

Page last updated: August 23, 2015

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