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Clinical Trials/CTRI/2017/07/009056
CTRI/2017/07/009056
Other
未知

A Non-Interventional, Multicenter, Prospective, Observational Study to Understand Usage and Effect of Daclatasvir use with Sofosbuvir for the TrEatmenT of Adults with Chronic Genotype 3 HCV Infections - DETACH

Torrent Pharmaceuticals Ltd0 sites54 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Torrent Pharmaceuticals Ltd
Enrollment
54
Status
Other
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
September 11, 2017
Last Updated
4 years ago
Study Type
Observational

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\.Patient willing to provide informed consent
  • 2\.Female or male patient aged 18 years or above
  • 3\.Subjects chronically infected with hepatitis C virus (HCV) genotype 3
  • 4\.Patient found positive for HCV RNA test
  • 5\.Screening laboratory values within clinically acceptable range
  • 6\.Treatment naïve and experienced patients without cirrhosis
  • 7\.Patients who are started on daclatasvir treatment in normal clinical practice setting
  • 8\.Patients must provide written consent form to use personal and/or health data prior to the entry into the study

Exclusion Criteria

  • 1\.HCV Genotypes other than genotype\-3 infection; mixed genotype infections
  • 2\.Pregnant or nursing female or male with pregnant female partner
  • 3\.Female or male with female partner planning to become pregnant while enrolled in this study
  • 4\.Co\-infection with HIV or hepatitis B virus (HBV)
  • 5\.Patients with evidence of cirrhosis or hepatocellular carcinoma
  • 6\.History of clinically significant illness or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol
  • 7\.Any contraindication for the administration of direct acting antivirals daclatasvir and sofosbuvir

Outcomes

Primary Outcomes

Not specified

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