Hepatitis C VirusNCT02592057
Safety and Efficacy of Sofosbuvir-based Regimens in Clinical Practice for the Treatment of Chronic Hepatitis C Virus Infection in India
An observational study of Hepatitis C Virus, run by Gilead Sciences at 26 sites in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C Virus
- What is being tested?
- SOF
- Type of treatment
- Pill or oral medicine
- How many people
- 532 participants
- Where
- 26 sitesIndia
- Study dates
- 30 Nov 2015to 23 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults residing in India aged ≥ 18 years, who are infected with HCV, and for whom the treating physicians in the participating clinics have prescribed a SOF-based regimen as per the approved prescribing information.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
India26 sites
Sanjivani Superspeciality Hospital Clinical Research Department
Ahmedabad, 380015
Saviour Hospital
Ahmedabad, 380015
Manipal Hospital
Bengaluru, Karnataka, 560017
BGS global Hospitals
Bengaluru, Karnataka, 560098
Postgraduate Institute of Medical Education and Research
Chandigarh, Uttarakhand, 160012
Global Hospitals & Health City
Chennai, Tamil Nadu, 600100
Sri Ramachandra Medical College and Research
Chennai, 600116
VGM Hospital
Coimbatore, Tamil Nadu, 641 005
Artemis Hospital
Gurgaon, Haryana, 122001
Global Hospitals
Hyderabad, Andhra Pradesh, 500 004
Aware Global Hospital
Hyderabad, 500035
S.R. Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan, 302001
SMS Medical College & Hospital
Jaipur, Rajasthan, 302004
Marudhar Hospital
Jaipur, Rajasthan, 302012
Lakeshore Hospital
Kochi, Kerala, 682040
Institute of Post Graduate Medical Education And Research
Kolkata, West Bengal, 700 020
KGMU Medical College
Lucknow, Uttar Pradesh, 226003
M.V. Hospital and Research Centre
Lucknow, 226003
K. R. M. Hospital & Research Centre
Lucknow, 226010
Dayanand Medical College & Hospital
Ludhiana, 144001
BYL Nair Hospital & T N Medical College
Mumbai, 400008
Midas Institute of Gastro-enterology
Nagpur, Maharashtra, 440 010
A.I.I.M.S.
New Delhi, Ansari Nagar, 110029
Sir Ganga Ram Hospital
New Delhi, 110060
Nirmal Hospital Pvt. Ltd.
Surat, Gujarat, 395002
Om Research Center, Om Surgical Center & Maternity Home
Varanasi, 221007
About this study
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
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.
- Conditions
- Hepatitis C Virus
- Being tested
- SOF
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOFDrug
Also called Sovaldi ®, GS-7977
SOF tablets administered orally once daily based on approved prescribing information
| Study group | Role | What they receive |
|---|---|---|
| SOF-based regimens | Adults with chronic HCV infection in India who are being treated with a SOF-based treatment regimen as per the approved prescribing information. Receives: Drug: SOF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse drug reactions (ADRs) during treatment and up to 4 weeks after discontinuation of a SOF-based regimen
Measured: Up to Posttreatment Week 4
Secondary outcomes (1)
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.
Measured: Posttreatment Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study start30 Nov 2015
- Primary completion30 Nov 2017
- Study completion23 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C VirusStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 532 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592057
- Sponsor's protocol ID
- GS-US-334-1775
- Status last verified
- May 2018
- First submitted
- 29 Oct 2015
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02592057
- Acronym / sponsor ID
- GS-US-334-1775
- Conditions
- Hepatitis C Virus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 532 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2015 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 23 Apr 2018 (actual)
- First posted
- 30 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SOF-based regimens | – | Drug: SOFAdults with chronic HCV infection in India who are being treated with a SOF-based treatment regimen as per the approved prescribing information. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults residing in India aged ≥ 18 years, who are infected with HCV, and for whom the treating physicians in the participating clinics have prescribed a SOF-based regimen as per the approved prescribing information.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOFAlso: Sovaldi ®, GS-7977SOF tablets administered orally once daily based on approved prescribing information | Drug | SOF-based regimens |
Primary outcome
Incidence of adverse drug reactions (ADRs) during treatment and up to 4 weeks after discontinuation of a SOF-based regimen
Time frame: Up to Posttreatment Week 4
1 secondary outcome
Proportion of participants with sustained virologic response (SVR) 12 weeks after discontinuation of therapy (SVR12)
Time frame: Posttreatment Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C Virus, run by Gilead Sciences at 26 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse drug reactions (ADRs) during treatment and up to 4 weeks after discontinuation of a SOF-based regimen (time frame: Up to Posttreatment Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2018.