PT-NANBHPhase 4NCT02485080
Safety, Tolerability, and Efficacy of 24 Weeks Simeprevir+Sofosbuvir for Chronic Hepatitis C Genotype 1
A Phase 4 study testing Simeprevir and Sofosbuvir in people with PT-NANBH, run by Stanford University at 2 sites in United States.
Trial summary
The goal of this pilot study is to examine both efficacy and tolerability in patients with HCV genotype 1 and mild decompensation with Child-Pugh-Turcott score of 6 or lower. The CPT score is used to assess the prognosis of chronic liver diseases, as well as the required strength and treatment and necessity of liver… Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- PT-NANBH
- What is being tested?
- Simeprevir and Sofosbuvir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2015to Jan 2016
- Phase
- Phase 4
- 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 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult 18-72 years
- Cirrhosis: defined by stage 4 on biopsy or noninvasive tests or presence of splenomegaly and platelet of 130K or lower, or presence of shrunken nodular liver on CT or MRI, or presence of varices or encephalopathy or ascites.
- HCV genotype 1 or indeterminate and later assessed at Screening and confirmed as genotype 1
Who cannot join
- Uncontrolled ascites, uncontrolled hepatic encephalopathy, or uncontrolled esophageal/gastric varices
- Co-infection with HIV or hepatitis B (HBV)
- CPT 7 or above, or MELD >10
- Total bilirubin 4.0 mg/dL or above
- CrCl (creatinine clearance) < 30 mL/min
- Any unstable active medical illnesses.
Show all 10Show fewer
- Active use of illicit substances, alcohol, or smoking.
- Any malignancy within last 5 years except for basal cell skin cancer that has been adequately treated or HCC within Milan or UCSF criteria, which will be acceptable
- Any prior treatment with direct acting antivirals (approved or investigational), including HCV protease inhibitors, such as SMV. Patients who received prior treatment with SOF, and/or NS5A inhibitors (e.g. ledipasvir or Daclatasvir) can be included in this study
- Platelet < 30 K/uL
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Yale University Medical Center
New Haven, Connecticut, 06520
Stanford University Medical Center
Palo Alto, California, 94304
About this study
Official title: Safety, Tolerability, and Efficacy of Simeprevir 150 mg Daily Plus Sofosbuvir 400 mg Daily for 24 Weeks in Patients With Chronic Hepatitis C Genotype 1 With CPT Score of 6 or Lower Who Are IFN-Intolerant or Unwilling to be Treated With IFN
The goal of this pilot study is to examine both efficacy and tolerability in patients with HCV genotype 1 and mild decompensation with Child-Pugh-Turcott score of 6 or lower. The CPT score is used to assess the prognosis of chronic liver diseases, as well as the required strength and treatment and necessity of liver transplantation. A higher CPT score denotes higher necessity of liver transplantation.
Read the detailed description
Key objectives of this study include:
- To describe efficacy (SVR) in a special population of patients with chronic hepatitis C who are not willing or not candidates for IFN-based therapy.
- To describe safety, tolerability, and treatment persistency in this patient population with advanced liver disease.
- Conditions
- PT-NANBH
- Being tested
- Simeprevir, Sofosbuvir
- Keywords
- hepatitis C, liver transplantation, genotype 1
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimeprevirDrug
Also called Olysio
SofosbuvirDrug
Also called Sovaldi
| Study group | Role | What they receive |
|---|---|---|
| Simeprevir + sofosbuvir daily, 24 weeks | Experimental | Eligible and consenting patients will be treated with sofosbuvir (SOF) 400 mg daily and simeprevir (SMV) 150 mg daily for 24 weeks. Both drugs will be administered orally, per manufacturers' instructions. Receives: Drug: Simeprevir; Drug: Sofosbuvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virologic response (SVR) HCV RNA PCR <25 IU/mL 12 weeks post-treatment
Measured: 12 weeks after end of treatment or virologic response after liver transplantation, whichever comes first, assessed up to 12 weeks after end of treatment
Secondary outcomes (1)
Serious adverse events, adverse events grade 3 and above
Measured: 24 weeks while on treatment and 24 weeks after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: Withdrawn due to lack of resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PT-NANBHStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC, Yale University
- Responsible party
- Principal investigator, Mindie H. Nguyen, Stanford University
- Investigators
- Mindie H Nguyen, MD, MAS, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485080
- Sponsor's protocol ID
- 33431
- Status last verified
- Oct 2016
- First submitted
- 23 Jun 2015
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Roche B, Samuel D. Hepatitis C virus treatment pre- and post-liver transplantation. Liver Int. 2012 Feb;32 Suppl 1:120-8. doi: 10.1111/j.1478-3231.2011.02714.x.
PubMed 22212582Carrion JA, Martinez-Bauer E, Crespo G, Ramirez S, Perez-del-Pulgar S, Garcia-Valdecasas JC, Navasa M, Forns X. Antiviral therapy increases the risk of bacterial infections in HCV-infected cirrhotic patients awaiting liver transplantation: A retrospective study. J Hepatol. 2009 Apr;50(4):719-28. doi: 10.1016/j.jhep.2008.11.015. Epub 2008 Dec 29.
PubMed 19217183Iacobellis A, Siciliano M, Perri F, Annicchiarico BE, Leandro G, Caruso N, Accadia L, Bombardieri G, Andriulli A. Peginterferon alfa-2b and ribavirin in patients with hepatitis C virus and decompensated cirrhosis: a controlled study. J Hepatol. 2007 Feb;46(2):206-12. doi: 10.1016/j.jhep.2006.08.020. Epub 2006 Oct 20.
PubMed 17125876
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, and Efficacy of Simeprevir 150 mg Daily Plus Sofosbuvir 400 mg Daily for 24 Weeks in Patients With Chronic Hepatitis C Genotype 1 With CPT Score of 6 or Lower Who Are IFN-Intolerant or Unwilling to be Treated With IFN
- ClinicalTrials.gov ID
- NCT02485080
- Acronym / sponsor ID
- 33431
- Conditions
- PT-NANBH
- Keywords
- hepatitis C, liver transplantation, genotype 1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn due to lack of resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC, Yale University
- Study start
- Sep 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 30 Jun 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.
The goal of this pilot study is to examine both efficacy and tolerability in patients with HCV genotype 1 and mild decompensation with Child-Pugh-Turcott score of 6 or lower. The CPT score is used to assess the prognosis of chronic liver diseases, as well as the required strength and treatment and necessity of liver transplantation. A higher CPT score denotes higher necessity of liver transplantation.
Detailed description
Key objectives of this study include:
- To describe efficacy (SVR) in a special population of patients with chronic hepatitis C who are not willing or not candidates for IFN-based therapy.
- To describe safety, tolerability, and treatment persistency in this patient population with advanced liver disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simeprevir + sofosbuvir daily, 24 weeks | Experimental | Drug: Simeprevir, Drug: SofosbuvirEligible and consenting patients will be treated with sofosbuvir (SOF) 400 mg daily and simeprevir (SMV) 150 mg daily for 24 weeks. Both drugs will be administered orally, per manufacturers' instructions. |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult 18-72 years
- Cirrhosis: defined by stage 4 on biopsy or noninvasive tests or presence of splenomegaly and platelet of 130K or lower, or presence of shrunken nodular liver on CT or MRI, or presence of varices or encephalopathy or ascites.
- HCV genotype 1 or indeterminate and later assessed at Screening and confirmed as genotype 1
Key exclusion criteria (10 listed)
- Uncontrolled ascites, uncontrolled hepatic encephalopathy, or uncontrolled esophageal/gastric varices
- Co-infection with HIV or hepatitis B (HBV)
- CPT 7 or above, or MELD >10
- Total bilirubin 4.0 mg/dL or above
- CrCl (creatinine clearance) < 30 mL/min
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 |
|---|---|---|
| SimeprevirAlso: Olysio | Drug | Simeprevir + sofosbuvir daily, 24 weeks |
| SofosbuvirAlso: Sovaldi | Drug | Simeprevir + sofosbuvir daily, 24 weeks |
Primary outcome
Sustained virologic response (SVR) HCV RNA PCR <25 IU/mL 12 weeks post-treatment
Time frame: 12 weeks after end of treatment or virologic response after liver transplantation, whichever comes first, assessed up to 12 weeks after end of treatment
1 secondary outcome
Serious adverse events, adverse events grade 3 and above
Time frame: 24 weeks while on treatment and 24 weeks after end of treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
- Background: PubMed 22212582Roche B, Samuel D. Hepatitis C virus treatment pre- and post-liver transplantation. Liver Int. 2012 Feb;32 Suppl 1:120-8. doi: 10.1111/j.1478-3231.2011.02714.x.
- Background: PubMed 19217183Carrion JA, Martinez-Bauer E, Crespo G, Ramirez S, Perez-del-Pulgar S, Garcia-Valdecasas JC, Navasa M, Forns X. Antiviral therapy increases the risk of bacterial infections in HCV-infected cirrhotic patients awaiting liver transplantation: A retrospective study. J Hepatol. 2009 Apr;50(4):719-28. doi: 10.1016/j.jhep.2008.11.015. Epub 2008 Dec 29.
- Background: PubMed 17125876Iacobellis A, Siciliano M, Perri F, Annicchiarico BE, Leandro G, Caruso N, Accadia L, Bombardieri G, Andriulli A. Peginterferon alfa-2b and ribavirin in patients with hepatitis C virus and decompensated cirrhosis: a controlled study. J Hepatol. 2007 Feb;46(2):206-12. doi: 10.1016/j.jhep.2006.08.020. Epub 2006 Oct 20.
- Recommendations for Testing, Managing, and Treating Hepatitis C by the American Association for the Study of Liver Diseases and Infectious Disease Society of AmericaLink provided by the sponsor.
- OLYSIO (Simeprevir) package insertLink provided by the sponsor.
- SOLVALDI (Sofosbuvir) package insertLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Mindie H Nguyen, MD, MAS principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Simeprevir and Sofosbuvir in people with PT-NANBH, run by Stanford University at 2 sites in United States.
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 10 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: withdrawn, as of the sponsor's last update on 13 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Sustained virologic response (SVR) HCV RNA PCR <25 IU/mL 12 weeks post-treatment (time frame: 12 weeks after end of treatment or virologic response after liver transplantation, whichever comes first, assessed up to 12 weeks after end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02485080, which also lists 3 linked publications.
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 13 Oct 2016.