Hepatitis C Virus Clinical Trial
Official title:
A Multicenter, Prospective, Observational, Post Marketing Surveillance Study to Evaluate the Safety and Efficacy of Sofosbuvir-based Regimens in Clinical Practice for the Treatment of Patients With Chronic Hepatitis C Virus Infection in India
| Verified date | May 2018 |
| Source | Gilead Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This study will evaluate the safety and efficacy of sofosbuvir (SOF)-based regimens administered as per the approved prescribing information in adults with chronic hepatitis C virus (HCV) infection treated in routine clinical practice in India.
| Status | Completed |
| Enrollment | 532 |
| Est. completion date | April 23, 2018 |
| Est. primary completion date | November 30, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - HCV-infected patients living in India - Treatment with a SOF-based regimen as determined by the patient's treating physician per the approved prescribing information. - Patients who provide written and signed informed consent prior to initiation of treatment where required. Exclusion Criteria: - Concurrent participation in an HCV clinical trial (except trials not testing investigational medicinal products) - Patients presenting a risk of not being able to be followed (eg, patients planning to move or leave the country in a foreseeable future) |
| Country | Name | City | State |
|---|---|---|---|
| India | Sanjivani Superspeciality Hospital Clinical Research Department | Ahmedabad | |
| India | Saviour Hospital | Ahmedabad | |
| India | BGS global Hospitals | Bengaluru | Karnataka |
| India | Manipal Hospital | Bengaluru | Karnataka |
| India | Postgraduate Institute of Medical Education and Research | Chandigarh | UT |
| India | Global Hospitals & Health City | Chennai | Tamil Nadu |
| India | Sri Ramachandra Medical College and Research | Chennai | |
| India | VGM Hospital | Coimbatore | Tamil Nadu |
| India | Artemis Hospital | Gurgaon | Haryana |
| India | Aware Global Hospital | Hyderabad | |
| India | Global Hospitals | Hyderabad | Andhra Pradesh |
| India | Marudhar Hospital | Jaipur | Rajasthan |
| India | S.R. Kalla Memorial Gastro & General Hospital | Jaipur | Rajasthan |
| India | SMS Medical College & Hospital | Jaipur | Rajasthan |
| India | Lakeshore Hospital | Kochi | Kerala |
| India | Institute of Post Graduate Medical Education And Research | Kolkata | West Bengal |
| India | K. R. M. Hospital & Research Centre | Lucknow | |
| India | KGMU Medical College | Lucknow | Uttar Pradesh |
| India | M.V. Hospital and Research Centre | Lucknow | |
| India | Dayanand Medical College & Hospital | Ludhiana | |
| India | BYL Nair Hospital & T N Medical College | Mumbai | |
| India | Midas Institute of Gastro-enterology | Nagpur | Maharashtra |
| India | A.I.I.M.S. | New Delhi | Ansari Nagar |
| India | Sir Ganga Ram Hospital | New Delhi | |
| India | Nirmal Hospital Pvt. Ltd. | Surat | Gujarat |
| India | Om Research Center, Om Surgical Center & Maternity Home | Varanasi |
| Lead Sponsor | Collaborator |
|---|---|
| Gilead Sciences |
India,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of adverse drug reactions (ADRs) during treatment and up to 4 weeks after discontinuation of a SOF-based regimen | Up to Posttreatment Week 4 | ||
| Secondary | Proportion of participants with sustained virologic response (SVR) 12 weeks after discontinuation of therapy (SVR12) | SVR12 is defined as HCV RNA < the lower limit of quantification (LLOQ) 12 weeks following the last dose of study drug, respectively. | Posttreatment Week 12 |
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