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| Name | Class |
|---|---|
| Pars No Tarkib Co | UNKNOWN |
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The purpose of this study is to evaluate the safety and efficacy of a locally produced 40KD pegylated interferon alpha-2a (Pegaferon) in patients with hepatitis C. 100 patients will be treated using standard guidelines for hepatitis C. Response to treatment and side effects will be recorded.
The product is locally produced and needs to be evaluated in terms of efficacy and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegaferon (pegylated interferon alpha 2a) + ribavirin | Drug | pegylated interferon 180 micrograms subcutaneously weekly - ribavirin (oral, in two divided daily doses) 800 mg for genotype 2 and 3, 1000 or 1200mg (weight less than or greater than 75kg) for genotypes 1 and 4 - Duration: 24 weeks for genotype 2 and 3, 48 weeks for genotypes 1 and 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained viral response | Negative hepatitis C viral RNA with a highly sensitive assay 6 months after end of treatment | 6 months after end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse drug events | Any adverse event reported by patient or seen in laboratory data | 18 months from start of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Reza Malekzadeh, MD | Tehran University of Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emam Hospital | Tehran | Iran | ||||
| Shariati Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20597564 | Derived | Jabbari H, Bayatian A, Sharifi AH, Zaer-Rezaee H, Fakharzadeh E, Asadi R, Zamini H, Shahzamani K, Merat S, Nassiri-Toosi M. Safety and efficacy of locally manufactured pegylated interferon in hepatitis C patients. Arch Iran Med. 2010 Jul;13(4):306-12. |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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|
|
| Tehran |
| Iran |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |