Liver FibrosisPhase 2NCT01707472
Study of Simtuzumab in HIV and/or Hepatitis C- Infected Adults With Liver Fibrosis
A Phase 2 study testing Simtuzumab in people with Liver Fibrosis and Hepatitis C, run by Gilead Sciences at 1 site in United States.
Trial summary
The primary objective of this study is to assess the safety and tolerability of simtuzumab (formerly GS-6624) in HIV and/or hepatitis C virus (HCV)-infected adults with evidence of liver fibrosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Fibrosis, Hepatitis C, HIV
- What is being tested?
- Simtuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2012to 17 Oct 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- HIV-infected individuals must have positive serologies with viral load suppressed below 400 copies/mL
- HCV-infected individuals must have:
- Chronic HCV infection with HCV RNA ≥ 2000 IU/ml AND at least 1 of the following:
- Been null responder to previous pegylated interferon and ribavirin therapy OR
- Failed to achieve sustained virologic response (SVR) on a regimen containing a direct-acting antiviral (DAA) in addition to pegylated interferon and ribavirin OR
- Are unwilling to receive or have contraindications to interferon therapy for HCV
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- HIV/HCV co-infected individuals must have:
- Positive HIV serologies with viral load suppressed below 400 copies/mL
- Chronic HCV infection with HCV RNA ≥ 2000 IU/ml AND at least 1 of the following:
- Been null responder to previous pegylated interferon and ribavirin therapy OR
- Failed to achieve SVR on a regimen containing a direct-acting antiviral (DAA) in addition to pegylated interferon and ribavirin OR
- Are unwilling to receive or have contraindications to interferon therapy for HCV
- Willing to allow blood and tissue samples to be stored for future use to study HIV infection, immune function, liver disease and additional mechanisms involved in liver fibrosis among patients with HIV and/or HCV, which may not be related directly to the specific objectives of this study protocol
- Have a primary care physician
Who cannot join
- Cause of liver fibrosis other than HCV or long-term antiretroviral therapy (ART) treatment for HIV
- Currently being treated for HCV
- Evidence of active Hepatitis A, B or D infections
- History or evidence of hepatocellular carcinoma
- Unwillingness to undergo a liver biopsy pre-treatment and post-treatment, or to undergo all other protocol required tests/procedures or return to the site for required visits
- Presence of contraindications to magnetic resonance imaging (e.g., presence of any metal in the body, cardiac or neural pacemaker, aneurysm clip, cochlear implant, claustrophobia)
Trial locations and contacts
1 site in 1 country.
United States1 site
NIH Department of Laboratory Medicine
Bethesda, Maryland, 20892
About this study
Official title: A Phase 2a Study of an Anti-LOXL2 Monoclonal Antibody (GS-6624) in HIV and/or Hepatitis C- Infected Subjects With Liver Fibrosis
The primary objective of this study is to assess the safety and tolerability of simtuzumab (formerly GS-6624) in HIV and/or hepatitis C virus (HCV)-infected adults with evidence of liver fibrosis.
- Conditions
- Liver Fibrosis, Hepatitis C, HIV, HIV/HCV Co-infection
- Being tested
- Simtuzumab
- Keywords
- Liver Fibrosis, Fibrosis, HIV, HCV, GS-6624, Hepatitis, Hepatitis C
- Medical subject headings
- Liver Cirrhosis, Hepatitis C, Fibrosis, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimtuzumabBiological
Also called Anti-LOXL2 Monoclonal Antibody, GS-6624
700 mg intravenously for a total of 12 infusions.
| Study group | Role | What they receive |
|---|---|---|
| Simtuzumab in HIV Patients | Experimental | HIV-infected participants will receive simtuzumab every 2 weeks for 24 weeks while continuing on standard therapy for HIV. Receives: Biological: Simtuzumab |
| Simtuzumab in HCV Patients | Experimental | HCV-infected participants will receive simtuzumab every 2 weeks for 24 weeks. Receives: Biological: Simtuzumab |
| Simtuzumab in HIV/HCV Co-Infected Patients | Experimental | HIV/HCV co-infected participants will receive simtuzumab every 2 weeks for 24 weeks while continuing on standard therapy for HIV. Receives: Biological: Simtuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Measured: First dose date up to Week 24 plus 30 days
Secondary outcomes (5)
Number of Participants With a Change From Baseline in Ishak Fibrosis Stage Score at Week 24
The Ishak fibrosis score measures the degree of liver fibrosis (scarring) and ranges from 0 (best) to 6 (worst). A negative value in change from baseline indicates an improvement and a positive value indicates worsening.
Measured: Baseline; Week 24
Change From Baseline in HVPG at Week 24
Measured: Baseline; Week 24
Change From Baseline in MQC at Week 24
Measured: Baseline; Week 24
Change From Baseline in Alpha SMA at Week 24
Measured: Baseline; Week 24
Change From Baseline in Liver Fibrosis as Estimated by MRE at Week 24
Measured: Baseline; Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study start4 Oct 2012
- Primary completion17 Oct 2014
- Study completion17 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Liver FibrosisStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT01707472
- Sponsor's protocol ID
- GS-US-321-0107
- Status last verified
- Oct 2019
- First submitted
- 11 Sep 2012
- Last updated
- 5 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Meissner EG, McLaughlin M, Matthews LA, Kanwar B, Bornstein JD, Kovacs JA, et al. Longitudinal hepatic and PBMC gene expression profiling of HIV and/or HCV-infected patients with advanced liver disease treated with simtuzumab, an anti-LOXL2 antibody [Abstract 448]. Hepatology AASLD Abstracts 2014;60 Number 4 (Suppl):421A.
Han MAT, Gharib AM, Zhao X, Sinkus R, Rizvi BS, Matthews L, et al. Noninvasive Measures of Severity in Chronic Liver Disease, Moving Beyond Fibrosis [Abstract Sa1006]. Digestive Disease Week; 2015 16-19 May; Washington, D.C.
Gharib AM, Han MAT, Meissner EG, Kleiner DE, Zhao X, McLaughlin M, Matthews L, Rizvi B, Abd-Elmoniem KZ, Sinkus R, Levy E, Koh C, Myers RP, Subramanian GM, Kottilil S, Heller T, Kovacs JA, Morse CG. Magnetic Resonance Elastography Shear Wave Velocity Correlates with Liver Fibrosis and Hepatic Venous Pressure Gradient in Adults with Advanced Liver Disease. Biomed Res Int. 2017;2017:2067479. doi: 10.1155/2017/2067479. Epub 2017 Apr 5.
PubMed 28480218Meissner EG, McLaughlin M, Matthews L, Gharib AM, Wood BJ, Levy E, Sinkus R, Virtaneva K, Sturdevant D, Martens C, Porcella SF, Goodman ZD, Kanwar B, Myers RP, Subramanian M, Hadigan C, Masur H, Kleiner DE, Heller T, Kottilil S, Kovacs JA, Morse CG. Simtuzumab treatment of advanced liver fibrosis in HIV and HCV-infected adults: results of a 6-month open-label safety trial. Liver Int. 2016 Dec;36(12):1783-1792. doi: 10.1111/liv.13177. Epub 2016 Jul 6.
PubMed 27232579
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Study of an Anti-LOXL2 Monoclonal Antibody (GS-6624) in HIV and/or Hepatitis C- Infected Subjects With Liver Fibrosis
- ClinicalTrials.gov ID
- NCT01707472
- Acronym / sponsor ID
- GS-US-321-0107
- Conditions
- Liver Fibrosis, Hepatitis C, HIV, HIV/HCV Co-infection
- Keywords
- Liver Fibrosis, Fibrosis, HIV, HCV, GS-6624, Hepatitis, Hepatitis C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 4 Oct 2012 (actual)
- Primary completion
- 17 Oct 2014 (actual)
- Study completion
- 17 Oct 2014 (actual)
- First posted
- 16 Oct 2012 (estimated)
- Results
- Posted 9 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to assess the safety and tolerability of simtuzumab (formerly GS-6624) in HIV and/or hepatitis C virus (HCV)-infected adults with evidence of liver fibrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Simtuzumab in HIV Patients | Experimental | Biological: SimtuzumabHIV-infected participants will receive simtuzumab every 2 weeks for 24 weeks while continuing on standard therapy for HIV. |
| Simtuzumab in HCV Patients | Experimental | Biological: SimtuzumabHCV-infected participants will receive simtuzumab every 2 weeks for 24 weeks. |
| Simtuzumab in HIV/HCV Co-Infected Patients | Experimental | Biological: SimtuzumabHIV/HCV co-infected participants will receive simtuzumab every 2 weeks for 24 weeks while continuing on standard therapy for HIV. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- HIV-infected individuals must have positive serologies with viral load suppressed below 400 copies/mL
- HCV-infected individuals must have:
- HIV/HCV co-infected individuals must have:
- Willing to allow blood and tissue samples to be stored for future use to study HIV infection, immune function, liver disease and additional mechanisms involved in liver fibrosis among patients with HIV and/or HCV, which may not be related directly to the specific objectives of this study protocol
- Have a primary care physician
Key exclusion criteria (6 listed)
- Cause of liver fibrosis other than HCV or long-term antiretroviral therapy (ART) treatment for HIV
- Currently being treated for HCV
- Evidence of active Hepatitis A, B or D infections
- History or evidence of hepatocellular carcinoma
- Unwillingness to undergo a liver biopsy pre-treatment and post-treatment, or to undergo all other protocol required tests/procedures or return to the site for required visits
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 |
|---|---|---|
| SimtuzumabAlso: Anti-LOXL2 Monoclonal Antibody, GS-6624700 mg intravenously for a total of 12 infusions. | Biological | Simtuzumab in HCV Patients, Simtuzumab in HIV Patients, Simtuzumab in HIV/HCV Co-Infected Patients |
Primary outcome
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Time frame: First dose date up to Week 24 plus 30 days
5 secondary outcomes
Number of Participants With a Change From Baseline in Ishak Fibrosis Stage Score at Week 24
Time frame: Baseline; Week 24
Change From Baseline in HVPG at Week 24
Time frame: Baseline; Week 24
Change From Baseline in MQC at Week 24
Time frame: Baseline; Week 24
Change From Baseline in Alpha SMA at Week 24
Time frame: Baseline; Week 24
Change From Baseline in Liver Fibrosis as Estimated by MRE at Week 24
Time frame: Baseline; Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundMeissner EG, McLaughlin M, Matthews LA, Kanwar B, Bornstein JD, Kovacs JA, et al. Longitudinal hepatic and PBMC gene expression profiling of HIV and/or HCV-infected patients with advanced liver disease treated with simtuzumab, an anti-LOXL2 antibody [Abstract 448]. Hepatology AASLD Abstracts 2014;60 Number 4 (Suppl):421A.
- BackgroundHan MAT, Gharib AM, Zhao X, Sinkus R, Rizvi BS, Matthews L, et al. Noninvasive Measures of Severity in Chronic Liver Disease, Moving Beyond Fibrosis [Abstract Sa1006]. Digestive Disease Week; 2015 16-19 May; Washington, D.C.
- Derived from this study: PubMed 28480218Gharib AM, Han MAT, Meissner EG, Kleiner DE, Zhao X, McLaughlin M, Matthews L, Rizvi B, Abd-Elmoniem KZ, Sinkus R, Levy E, Koh C, Myers RP, Subramanian GM, Kottilil S, Heller T, Kovacs JA, Morse CG. Magnetic Resonance Elastography Shear Wave Velocity Correlates with Liver Fibrosis and Hepatic Venous Pressure Gradient in Adults with Advanced Liver Disease. Biomed Res Int. 2017;2017:2067479. doi: 10.1155/2017/2067479. Epub 2017 Apr 5.
- Derived from this study: PubMed 27232579Meissner EG, McLaughlin M, Matthews L, Gharib AM, Wood BJ, Levy E, Sinkus R, Virtaneva K, Sturdevant D, Martens C, Porcella SF, Goodman ZD, Kanwar B, Myers RP, Subramanian M, Hadigan C, Masur H, Kleiner DE, Heller T, Kottilil S, Kovacs JA, Morse CG. Simtuzumab treatment of advanced liver fibrosis in HIV and HCV-infected adults: results of a 6-month open-label safety trial. Liver Int. 2016 Dec;36(12):1783-1792. doi: 10.1111/liv.13177. Epub 2016 Jul 6.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Simtuzumab in people with Liver Fibrosis and Hepatitis C, run by Gilead Sciences at 1 site 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 14 inclusion and 6 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 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (time frame: First dose date up to Week 24 plus 30 days). 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 NCT01707472, which also lists 4 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 5 Nov 2019.