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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00707850
• Other study ID #: BRCGL-08-06
• Status: Completed
• Phase: Phase 4
• First received: June 26, 2008
• Last updated: August 30, 2010
• Start date: May 2007
• Est. completion date: September 2009

Study information

• Verified date: September 2009
• Source: Baqiyatallah Medical Sciences University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Thalassemia

Intervention

Drug:
• PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)
PEGASYS: 180 microgram per week (Injection) Plus Ribavirin: [=<75 kg: 1000 mg; >75 kg: 1200 mg per day (PO)]

Locations

Country	Name	City	State
Iran, Islamic Republic of	Baqiyatallah Research Center for Gastroenterology and Liver Diseases	Tehran

Sponsors (5)

Lead Sponsor	Collaborator
Baqiyatallah Medical Sciences University	Baqiyatallah Research Center for Gastroenterology and Liver Diseases, Guilan Research Center for Gastroenterology and Liver Diseases, Tabriz Research Center for Gastroenterology and Liver Diseases, Tehran Hepatitis Center

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early Virologic Response		After 12 weeks of Treatment	No
Primary	End of Treatment Response		48 Weeks	No
Primary	Sustained Virologic Response		24 weeks after Treatment	No
Primary	Rapid Virologic Response		One month after Treatment	No
Secondary	Tolerability of drugs for whole therapy period		During Treatment	Yes
Secondary	Biochemical response (ALT)		End of Treatment AND 24 weeks after Treatment	No
Secondary	Laboratory Parameters		During Treatment AND End of treatment	No