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Efficacy & Safety of Velpatasvir-Sofosbuvir combination in treatment of Hepatitis-C patients of Pakistan, Phase-IV Interventional Trial

A prospective, interventional, multi-center trial to evaluate the Efficacy and Safety of Sofosbuvir-Velpatasvir for the treatment of Chronic Hepatitis C patients in Pakistan.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20170614034526N4
Enrollment
155
Registered
2019-03-28
Start date
2018-04-02
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis-C. Chronic viral hepatitis C

Interventions

Intervention group: Sofosbuvir 400 mg + Velpatasvir 100 mg once daily for 12 weeks.

Sponsors

Hilton Pharma Pvt Ltd
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Subjects willing to undergo screening and sign informed consent Male or female outpatients =18 years of age Serologically and histologically proven CHC, detectable HCV RNA, elevated ALT, and compensated liver disease.

Exclusion criteria

Exclusion criteria: Unable to give written informed consent Pregnant and/or Nursing Women Contraindicated to medicine or any of the component of prescribed therapy

Design outcomes

Primary

MeasureTime frame
Sustained Virologic Response (SVR). Timepoint: Assessed at week 24 from the baseline visit or start of therapy. Method of measurement: HCV-RNA PCR.

Secondary

MeasureTime frame
End of Treatment Response (ETR). Timepoint: assessed at week 12 from baseline visit or start of therapy. Method of measurement: HCV-RNA PCR.;Adverse Events or Serious Adverse Events. Timepoint: assessed at week 04, week 12 & week 24 follow-up visits. Method of measurement: Clinical examination or history by study participants.

Countries

Pakistan

Contacts

Public ContactDr. Nazish Butt

Jinnah Post graduate Medical Center

dr.nazishbutt@gmail.com+92 21 99201300

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 19, 2026