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Clinical Trials/CTRI/2015/02/005494
CTRI/2015/02/005494
Other
Phase 4

Efficacy and safety of PEG-Inferon (peginterferon alpha-2b) for the treatment of chronic hepatitis C - An open-label multicentre study in India.

Virchow Biotech Pvt Ltd0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: B182- Chronic viral hepatitis C

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Health Condition 1: B182- Chronic viral hepatitis C
Sponsor
Virchow Biotech Pvt Ltd
Status
Other
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\.Adult male or female between 18\-65 years (both years inclusive).
  • •2\.Patient with chronic hepatitis C infection.
  • •3\. Presence of serum alanine aminotransferase (ALT)
  • •levels 1\.5 times greater than normal (N \<40 IU/litre).
  • •4\.Compensated liver disease at the time of baseline
  • •visit as defined by Child\-Pugh class A.
  • •5\.Hemoglobin \>\=9 g/dL (females), \>\=10 g/dL (males); platelet count \>\=75 Ã? 109/L; neutrophil count \>\=1\.5 Ã? 109/L; thyroid stimulating hormone (TSH) within normal limits (0\.35 â?? 5\.50 mIU/mL).
  • •6\.Willing to give written informed consent and adhere to study visit schedule

Exclusion Criteria

  • •1\.Any evidence of other liver diseases HAV, HBV, HDV, alpha 2 anti\-trypsin deficiency, Wilsonâ??s disease, primary biliary cirrhosis, alcoholic liver disease or autoimmune liver disease, hemochromatosis.
  • •2\.A chronic alcoholic or patient with drug abuse problem or severe psychiatric condition.
  • •3\.Pregnant or intent to be pregnant during the study period or nursing mothers.
  • •4\.Patient with immune suppression associated with organ transplantation especially liver transplantation.
  • •5\.History of hypersensitivity to interferon or its diluents. Significant psychiatric disease especially depression.
  • •6\.Severe cardiovascular disease.
  • •7\.Patient with human immunodeficiency virus (HIV) infection.

Outcomes

Primary Outcomes

Not specified

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