Liver FibrosisPhase 2NCT01452308
Pilot Study of Simtuzumab in the Treatment of Liver Fibrosis
A Phase 2 study testing Simtuzumab in people with Liver Fibrosis, run by Gilead Sciences at 1 site in United States.
Trial summary
This study will evaluate the safety and tolerability of simtuzumab (GS-6624) in patients with fibrosis of the liver. Up to 20 participants will be enrolled into two sequential cohorts. Cohort 1 will consist of 10 participants who will receive simtuzumab every other week for a total of 3 infusions. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Fibrosis
- 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
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Aug 2013
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females 18 - 65 years of age
- Chronic liver disease of any etiology
- Stage 1-3 fibrosis by Metavir score on a liver biopsy.
- Body mass index <36 kg/m2
Who cannot join
- Any evidence of hepatic decompensation past or present
- Subjects currently abusing amphetamines, cocaine, opiates, or alcohol
- Clinically significant cardiac disease
- History of cancer, other than non-melanomatous skin cancer, within 5 years prior to Screening
- Systemic fungal, bacterial, viral, or other infection that is not controlled
- Use of systemic immunosuppressants within 28 days of the Pre-treatment Phase
Show all 9Show fewer
- Use of approved therapy for hepatitis C or hepatitis B virus within 28 days of the Pre-treatment Phase
- Pregnant or lactating
- History of bleeding diathesis within the last 6 months of study Day 1
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College: NewYork-Presbyterian Hospital
New York, New York, 10065
About this study
Official title: A Phase 2a, Pilot, Open-Label Trial Evaluating the Safety, Tolerability and Pharmacodynamic Effects of GS-6624 in Subjects With Fibrosis of the Liver
This study will evaluate the safety and tolerability of simtuzumab (GS-6624) in patients with fibrosis of the liver.
Up to 20 participants will be enrolled into two sequential cohorts. Cohort 1 will consist of 10 participants who will receive simtuzumab every other week for a total of 3 infusions. Participants in Cohort 2 (10 subjects) will also receive simtuzumab every other week for a total of 3 infusions; the dose will depend on the safety and tolerability of simtuzumab seen in Cohort 1.
Participants from both cohorts who have completed the main study will be allowed to continue on simtuzumab treatment for an additional extension period, and will receive up to 13 additional infusions of simtuzumab at a fixed dose of 700 mg for an additional 24 weeks.
- Conditions
- Liver Fibrosis
- Being tested
- Simtuzumab
- Keywords
- Gilead, Gilead Sciences, GSI, Liver Fibrosis, Liver, Fibrosis
- Medical subject headings
- Liver Cirrhosis, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimtuzumabBiological
Also called GS-6624
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Participants will receive simtuzumab at a dose of 10 mg/kg by intravenous (IV) infusion every other week for a total of 3 infusions. Receives: Biological: Simtuzumab |
| Cohort 2 | Experimental | Participants will receive simtuzumab IV every other week for a total of 3 infusions. The dose will depend on the safety and tolerability of simtuzumab seen in Cohort 1 but will not exceed 20 mg/kg. Receives: Biological: Simtuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events on multiple, escalating IV doses of simtuzumab
The endpoints to be evaluated will include graded Adverse Events, laboratory abnormalities, and vital sign measurements
Measured: Through Week 14
Secondary outcomes (4)
Assessment of serum concentration of simtuzumab
Trough concentrations will be summarized by day, treatment and dose.
Measured: Through Week 14
Antibody formation to simtuzumab (anti-simtuzumab Abs)
Immunogenicity endpoints will be geometric mean titer (GMT) and geometric mean fold rate (GMFR) for a select set of antibodies.
Measured: Through Week 14
Measurement of pharmacodynamic (PD) markers after administration of simtuzumab
Pharmacodynamic markers include: Tissue PD markers through mRNA expression, LOXL2, LOX, Other LOXL proteins, αSMA, Collagen 1A1, NFKB1, Caspase 1, SMAD, and NOD; Serum and plasma PD markers include: APRI, LOXL2, Osteopontin, Hyaluronic Acid, CXCL 9, 10 and 11, MMP1, MMP3, MMP9, TIMP1, CD40L, TGF-β1, ET-1, VEGF, GAL3, IL-6 / IL-8 / TNFα / IFNγ, α2-macroglobulin, Apolipoprotein A1.
Measured: Through Week 14
Assessing the effects of chronic dosing of simtuzumab on liver structure and fibrotic markers
Measuring the effect of an additional 24 weeks of simtuzumab dosing on liver histology, LOXL2 and mRNA expression in the liver and serum markers of liver fibrosis
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionJan 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Bornstein, MD, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452308
- Sponsor's protocol ID
- GS-US-321-0101
- Status last verified
- Jan 2014
- First submitted
- 11 Oct 2011
- Last updated
- 3 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Pilot, Open-Label Trial Evaluating the Safety, Tolerability and Pharmacodynamic Effects of GS-6624 in Subjects With Fibrosis of the Liver
- ClinicalTrials.gov ID
- NCT01452308
- Acronym / sponsor ID
- GS-US-321-0101
- Conditions
- Liver Fibrosis
- Keywords
- Gilead, Gilead Sciences, GSI, Liver Fibrosis, Liver, Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 14 Oct 2011 (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 tolerability of simtuzumab (GS-6624) in patients with fibrosis of the liver.
Up to 20 participants will be enrolled into two sequential cohorts. Cohort 1 will consist of 10 participants who will receive simtuzumab every other week for a total of 3 infusions. Participants in Cohort 2 (10 subjects) will also receive simtuzumab every other week for a total of 3 infusions; the dose will depend on the safety and tolerability of simtuzumab seen in Cohort 1.
Participants from both cohorts who have completed the main study will be allowed to continue on simtuzumab treatment for an additional extension period, and will receive up to 13 additional infusions of simtuzumab at a fixed dose of 700 mg for an additional 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: SimtuzumabParticipants will receive simtuzumab at a dose of 10 mg/kg by intravenous (IV) infusion every other week for a total of 3 infusions. |
| Cohort 2 | Experimental | Biological: SimtuzumabParticipants will receive simtuzumab IV every other week for a total of 3 infusions. The dose will depend on the safety and tolerability of simtuzumab seen in Cohort 1 but will not exceed 20 mg/kg. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females 18 - 65 years of age
- Chronic liver disease of any etiology
- Stage 1-3 fibrosis by Metavir score on a liver biopsy.
- Body mass index <36 kg/m2
Key exclusion criteria (9 listed)
- Any evidence of hepatic decompensation past or present
- Subjects currently abusing amphetamines, cocaine, opiates, or alcohol
- Clinically significant cardiac disease
- History of cancer, other than non-melanomatous skin cancer, within 5 years prior to Screening
- Systemic fungal, bacterial, viral, or other infection that is not controlled
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: GS-6624 | Biological | Cohort 1, Cohort 2 |
Primary outcome
Incidence of adverse events on multiple, escalating IV doses of simtuzumab
Time frame: Through Week 14
The endpoints to be evaluated will include graded Adverse Events, laboratory abnormalities, and vital sign measurements
4 secondary outcomes
Assessment of serum concentration of simtuzumab
Time frame: Through Week 14
Antibody formation to simtuzumab (anti-simtuzumab Abs)
Time frame: Through Week 14
Measurement of pharmacodynamic (PD) markers after administration of simtuzumab
Time frame: Through Week 14
Assessing the effects of chronic dosing of simtuzumab on liver structure and fibrotic markers
Time frame: Up to 24 weeks
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 3 Feb 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.
Jeffrey Bornstein, MD 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, 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 4 inclusion and 9 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 3 Feb 2014. 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?
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 events on multiple, escalating IV doses of simtuzumab (time frame: Through Week 14). 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 3 Feb 2014.