Post-transplant Hepatitis CNCT01779518
Expanded Access Program of Sofosbuvir With Ribavirin and With or Without Pegylated Interferon in Aggressive Post-transplant Hepatitis C
A study testing Sofosbuvir, Ribavirin and Pegylated Interferon in people with Post-transplant Hepatitis C, run by Gilead Sciences.
Trial summary
This is a single arm, open-label study which will be opened at specific clinical sites at the request of an investigator for the treatment of individual subjects for whom there are no other treatment options. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-transplant Hepatitis C
- What is being tested?
- Sofosbuvir, Ribavirin and Pegylated Interferon
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Adult, Older adult
Who may be able to join
- Age > or = 18 years
- Previously undergone orthotopic liver transplant (OLT) at least 2 months prior to the planned start of dosing
- Aggressive Hepatitis C infection (including fibrosing cholestatic hepatitis C)
- Life expectancy of < 12 months if the HCV is left untreated
Who cannot join
- History of clinically significant drug allergy to nucleoside/nucleotide analogs
- Participation in a clinical study with an investigational drug or biologic within 1 month prior to anticipated dose administration, unless information is available to determine that there is no safety or drug-drug interaction risk to the subject
- Unable or unwilling to follow the contraception requirements
About this study
Official title: An Expanded Access Phase 2 Study of Sofosbuvir With Ribavirin and With or Without Pegylated Interferon for 24 Weeks in Subjects Who Have Undergone Liver Transplantation and Who Have Aggressive, Recurrent Hepatitis C Infection
This is a single arm, open-label study which will be opened at specific clinical sites at the request of an investigator for the treatment of individual subjects for whom there are no other treatment options. Subjects will be treated for 24 weeks with sofosbuvir (400mg QD) with RBV; pegylated interferon may be added at the discretion of the investigator.
- Conditions
- Post-transplant Hepatitis C
- Being tested
- Sofosbuvir, Ribavirin, Pegylated Interferon
- Keywords
- HCV, Sustained Virologic Response, Direct Acting Antiviral, GS-7977, Pegylated interferon, Ribavirin, Open Label, Sofosbuvir, Liver transplant, Hepatitis, Hepatitis, Chronic, Hepatitis C, Hepatitis C, Chronic, Liver Diseases, Digestive System Diseases, Hepatitis, Viral, Human, Virus Diseases, Enterovirus Infections, Picornaviridae Infections, RNA Virus Infections
- Medical subject headings
- Hepatitis, Hepatitis, Chronic, Hepatitis C, Hepatitis C, Chronic, Liver Diseases, Digestive System Diseases, Hepatitis, Viral, Human, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SofosbuvirDrug
Also called GS-7977, PSI-7977, Sovaldi™
RibavirinDrug
Pegylated InterferonDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-transplant Hepatitis CStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779518
- Sponsor's protocol ID
- GS-US-334-0139
- Status last verified
- Jan 2014
- First submitted
- 23 Jan 2013
- Last updated
- 16 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Expanded Access Phase 2 Study of Sofosbuvir With Ribavirin and With or Without Pegylated Interferon for 24 Weeks in Subjects Who Have Undergone Liver Transplantation and Who Have Aggressive, Recurrent Hepatitis C Infection
- ClinicalTrials.gov ID
- NCT01779518
- Acronym / sponsor ID
- GS-US-334-0139
- Conditions
- Post-transplant Hepatitis C
- Keywords
- HCV, Sustained Virologic Response, Direct Acting Antiviral, GS-7977, Pegylated interferon, Ribavirin, Open Label, Sofosbuvir
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- First posted
- 30 Jan 2013 (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 is a single arm, open-label study which will be opened at specific clinical sites at the request of an investigator for the treatment of individual subjects for whom there are no other treatment options. Subjects will be treated for 24 weeks with sofosbuvir (400mg QD) with RBV; pegylated interferon may be added at the discretion of the investigator.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > or = 18 years
- Previously undergone orthotopic liver transplant (OLT) at least 2 months prior to the planned start of dosing
- Aggressive Hepatitis C infection (including fibrosing cholestatic hepatitis C)
- Life expectancy of < 12 months if the HCV is left untreated
Key exclusion criteria (3 listed)
- History of clinically significant drug allergy to nucleoside/nucleotide analogs
- Participation in a clinical study with an investigational drug or biologic within 1 month prior to anticipated dose administration, unless information is available to determine that there is no safety or drug-drug interaction risk to the subject
- Unable or unwilling to follow the contraception requirements
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 |
|---|---|---|
| SofosbuvirAlso: GS-7977, PSI-7977, Sovaldi™ | Drug | – |
| Ribavirin | Drug | – |
| Pegylated Interferon | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sofosbuvir, Ribavirin and Pegylated Interferon in people with Post-transplant Hepatitis C, run by Gilead Sciences.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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.
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 16 Jan 2014.