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Short term Efficacy and Safety of Alpha Interferon -2b (Pasture Made) plus Ribavirin for Treatment of the Patients with Chronic Hepatitis C

Protocol summary

Summary
Aim: to assess the safety and efficacy of regimen of Alpha Interferon -2b (Pasture Made) plus Ribavirin in a number of Iranian patients with chronic hepatitis C. Inclusion Criteria: older than 18 years, HCV RNA in serum on polymerase-chain-reaction (PCR) assay Exclusion Criteria: decompensated cirrhosis, autoimmune disease, evidence of cancer on ultrasonography or a high serum alfa-fetoprotein concentration, co-infection with HBV or HIV, neutropenia (neutrophil count <1500 cells/mm3), thrombocytopenia (platelet count <90,000 cells/mm3), anemia (hemoglobin level <12 gr/dl for women and <13 gr/dl for men), creatinine concentration more than 1.5 times the upper limit of normal range, organ transplantation, neoplastic disease, severe cardiac or chronic pulmonary disease, poorly controlled psychiatric disorder, seizure disorder, retinopathy, active drug or alcohol abuse, pregnancy in patient or spouse or unwillingness to use contraception Sample size: 40 patients Intervention: Patients assigned to receive subcutaneous treatment with Alpha Interferon -2b (Pasture made) Every other day plus oral treatment with Ribavirin 10-15 mg/kg per day. Primary outcome: rapid virologic response (RVR)

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138812123307N4
Registration date: 2010-03-03, 1388/12/12
Registration timing: prospective

Last update:
Update count: 0
Registration date
2010-03-03, 1388/12/12
Registrant information
Name
Seyed Moayed Alavian
Name of organization / entity
BRCGL-THC
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 2072
Email address
info@brcgl.ir
Recruitment status
Recruitment complete
Funding source
Pasteur Institute of Iran (IPI)
Expected recruitment start date
2010-04-01, 1389/01/12
Expected recruitment end date
2012-08-01, 1391/05/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Short term Efficacy and Safety of Alpha Interferon -2b (Pasture Made) plus Ribavirin for Treatment of the Patients with Chronic Hepatitis C
Public title
Short term Efficacy and Safety of Alpha Interferon -2b (Pasture Made) plus Ribavirin for Treatment of the Patients with Chronic Hepatitis C
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Impossibility for administration of peg-interferon according to recommendation of relevant specialist, older than 18 years, HCV RNA in serum on polymerase-chain-reaction (PCR) assay Exclusion Criteria: decompensated cirrhosis, autoimmune disease, evidence of cancer on ultrasonography or a high serum alfa-fetoprotein concentration, co-infection with HBV or HIV, neutropenia (neutrophil count <1500 cells/mm3), thrombocytopenia (platelet count <90,000 cells/mm3), anemia (hemoglobin level <12 gr/dl for women and <13 gr/dl for men), creatinine concentration more than 1.5 times the upper limit of normal range, organ transplantation, neoplastic disease, severe cardiac or chronic pulmonary disease, poorly controlled psychiatric disorder, seizure disorder, retinopathy, active drug or alcohol abuse, pregnancy in patient or spouse or unwillingness to use contraception.
Age
From 18 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Baqyatallah University of Medical Sciences
Street address
Baqyatallah University of Medical Sciences, Mollasdra Ave., Vanak Squ
City
Tehran
Postal code
Approval date
empty
Ethics committee reference number
5758

Health conditions studied

1

Description of health condition studied
Chronic Hepatitis C
ICD-10 code
B18.2
ICD-10 code description
Chronic viral hepatitis C

Primary outcomes

1

Description
rapid virologic response (RVR)
Timepoint
1 month after treatment initiation
Method of measurement
PCR

Secondary outcomes

1

Description
sustained virologic response (SVR)
Timepoint
Every 3 months
Method of measurement
PCR

Intervention groups

1

Description
Subcutaneous treatment with Alpha Interferon -2b (Pasture Made) Every other day plus oral treatment with ribavirin 10-15 mg/kg per day for 24 to 48 weeks according to the genotype of virus.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran Hepatitis Center
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Pasteur Institute of Iran (IPI)
Full name of responsible person
Dr sayaed Moayed Alavian
Street address
NO. 69, Pasteur Ave., po code:13164
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pasteur Institute of Iran (IPI)
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Full name of responsible person
Mehrdad Nooranipour
Position
M.D
Other areas of specialty/work
Street address
Ground Floor of Baqiyatallah Hospital, Baqiyatallah Medical University, Mollasdra Ave., Vanak Squ
City
Tehran
Postal code
Phone
+98 21 8861 4523
Fax
Email
manager@hepmon.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Full name of responsible person
Sayed Moayed Alavian
Position
M.D
Other areas of specialty/work
Street address
Ground Floor of Baqiyatallah Hospital, Baqiyatallah Medical University, Mollasdra Ave., Vanak Squ
City
Tehran
Postal code
Phone
+98 21 8861 4523
Fax
Email
editor@hepmon.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Full name of responsible person
Mostafa Shafiei
Position
M.D
Other areas of specialty/work
Street address
Ground Floor of Baqiyatallah Hospital, Baqiyatallah Medical University, Mollasdra Ave., Vanak Squ
City
Tehran
Postal code
Phone
+98 21 8861 4523
Fax
Email
mostafa.gilani@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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