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Nonalcoholic SteatohepatitisPhase 2NCT00740610

Safety, Tolerability, Pharmacokinetics and Activity of GS-9450 in Adults With Non-Alcoholic Steatohepatitis (NASH)

A Phase 2 study testing GS-9450 in people with Nonalcoholic Steatohepatitis, run by Gilead Sciences at 33 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The overall purpose of this study is to examine the safety, tolerability, pharmacokinetics (how the body processes a drug), and activity of GS-9450 in preventing liver damage due to scarring, or fibrosis, caused by Non-Alcoholic Steatohepatitis (also known as NASH). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Nonalcoholic Steatohepatitis
What is being tested?
GS-9450
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
124 participants
Where
33 sitesin 2 countries
Study dates
Aug 2008to Sep 2009
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-75 years of age
  • ALT > 60 U/L
  • fatty liver on screening ultrasound
  • and biopsy-confirmed NASH
  • platelet count >/= 75,000/mm3 and adequate hematologic function (absolute neutrophil count >/= 1,500/mm3, hemoglobin >/= 11.0 g/dL)
  • calculated creatinine clearance >/= 70 mL/min
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  • non-insulin dependent diabetes for < 10 years is allowed if stably managed for at least 6 months prior to screening
  • stable weight (no weight loss > 4%) for 8 weeks prior to screening and should maintain consistent diet, food intake, and physical exercise during the study
  • must have been on stable therapy for at least 3 months prior to screening if receiving 3-hydroxy-3-methylglutaryl-coenzyme (HMG-CoA) reductase inhibitors, niacin, fibrates, vitamin E or angiotensin receptor blockers
  • must have been on a stable treatment regimen for at least 3 months prior to screening if receiving other drugs possibly associated with hepatic adverse events (e.g., isoniazid, itraconazole, ketoconazole, rifabutin, rifampin, and other agents with significant hepatotoxic potential)

Who cannot join

  • Insulin dependent diabetes mellitus, treatment with sulfonylureas (may be allowed pending results from a drug-drug interaction study), subjects receiving glitazones at screening or within 6 months of screening, presence of diabetic peripheral neuropathy or gastroparesis
  • A > 4% decrease in weight within 8 weeks of screening
  • cirrhosis or decompensated liver disease (defined as conjugated bilirubin > 1.5 x the upper limit of the normal range (ULN), prothrombin time > 1.5 x ULN, serum albumin < 3.0 g/dL, or prior history of clinical hepatic decompensation
  • presence of other form of liver disease other than NASH
  • history of excess alcohol ingestion, averaging > 3 drinks/day in the previous 2 years; or current alcohol intake averaging > 2 drinks/day for females and > 3 drinks per day for males; history of or current binge drinking
  • serological evidence of co-infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV
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  • evidence of hepatocellular carcinoma (i.e., α-fetoprotein > 50 ng/mL)
  • history of ingesting drugs possibly associated with hepatic steatosis within the past year
  • history of total parenteral nutrition within the past 6 months
  • prior history of gastroplasty, jejunoileal, or jejunocolonic bypass surgery
  • history of ingesting drugs within the past 3 months that may improve NASH and associated fibrosis
  • significant gastrointestinal disease that would interfere with absorption of oral medications; inflammatory bowel disease
  • major surgery within the past year
  • clinically significant abnormalities on ECG or other ECG findings that the investigator considers a safety risk
  • significant systemic or major illnesses other than liver disease that, in the opinion of the investigator, would preclude treatment and adequate follow up
  • prior or current malignancy involving any organ system and skin cancer (previously excised basal cell carcinoma allowed)
  • acute ongoing infection, or symptoms of infection
  • pregnant or breastfeeding females
  • acute substance abuse within the past year.
  • history of ingesting anti-TNFα drugs or immunomodulators within the past 3 months

Trial locations and contacts

33 sites in 2 countries.

33 sites in 2 countries

United States31 sites

  • Study site

    Ann Arbor, Michigan, 48109

  • Study site

    Asheville, North Carolina

  • Study site

    Atlanta, Georgia, 30309

  • Study site

    Charlottesville, Virginia

  • Study site

    Chicago, Illinois

  • Study site

    Clevleand, Ohio

  • Study site

    Dallas, Texas, 75203

  • Study site

    Des Moines, Iowa

  • Study site

    Durham, North Carolina

  • Study site

    Falls Church, Virginia

  • Study site

    Fresno, California

  • Study site

    Fullerton, California

  • Study site

    Galveston, Texas, 77555

  • Study site

    Irving, Texas

  • Study site

    Jacksonville, Florida

  • Study site

    Kansas City, Kansas, 66160

  • Study site

    Lakewood, Colorado

  • Study site

    Marietta, Georgia

  • Study site

    Monroe, Louisiana

  • Study site

    New Orleans, Louisiana

  • Study site

    New York, New York

  • Study site

    Plainview, New York

  • Study site

    Providence, Rhode Island, 02905

  • Study site

    Raleigh, North Carolina

  • Study site

    Richmond, Virginia

  • Study site

    San Diego, California, 92161

  • Study site

    San Mateo, California

  • Study site

    Syracuse, New York

  • Study site

    Troy, Michigan

  • Study site

    Tucson, Arizona

  • Study site

    Washington D.C., District of Columbia

Other trials in United States

France2 sites

  • Study site

    Paris, 75020

  • Study site

    Vandœuvre-lès-Nancy, 54511

Other trials in France

About this study

Official title: A Phase 2, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Activity of GS 9450 in Adults With Non-Alcoholic Steatohepatitis (NASH)

The overall purpose of this study is to examine the safety, tolerability, pharmacokinetics (how the body processes a drug), and activity of GS-9450 in preventing liver damage due to scarring, or fibrosis, caused by Non-Alcoholic Steatohepatitis (also known as NASH).

Read the detailed description

This is a Phase 2, randomized, double-blind, parallel group, placebo controlled, multicenter study investigating the safety, tolerability, pharmacokinetics and activity of multiple oral doses of GS 9450 in adults with NASH. Approximately 110 subjects 18 75 years of age with elevated ALT (> 60 U/L at screening), fatty liver on screening ultrasound, and biopsy-proven NASH will be randomized (1:1:1:1:1) to one of five parallel treatment groups (22 subjects per treatment group) as follows:

GS-9450 1mg by mouth (PO) once daily, GS-9450 5 mg PO once daily, GS-9450 10 mg PO once daily, GS-9450 40 mg PO once daily, or Matching placebo PO once daily Qualifying subjects will be stratified by the presence/absence of type 2 diabetes (i.e., on/off oral diabetic medication at entry) and by geographic region (US and France). Following randomization, subjects will return within five business days later for a baseline visit, at which time they will be dispensed study medication and enter a 4-week treatment phase. Upon completion of the treatment phase, subjects will enter a 4 week off-treatment follow-up period. Each subject's participation in the study will last up to approximately 12 weeks (inclusive of screening, treatment phase, and off-treatment follow-up period).

Being tested
GS-9450, GS-9450 Placebo
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GS-9450Drug

    GS-9450 capsules at a dose of 1, 5, 10, and 40 mg administered orally once daily

  • GS-9450 PlaceboDrug

    Placebo to match GS-9450 administered orally once daily

Study groups in NCT00740610
Study groupRoleWhat they receive
Cohort 1Experimental22 subjects to receive 1 mg GS-9450 for 4 weeks
Receives: Drug: GS-9450
Cohort 2Experimental22 subjects to receive 5 mg GS-9450 for 4 weeks
Receives: Drug: GS-9450
Cohort 3Experimental22 subjects to receive 10 mg GS-9450 for 4 weeks
Receives: Drug: GS-9450
Cohort 4Experimental22 subjects to receive 40 mg GS-9450 for 4 weeks
Receives: Drug: GS-9450
Cohort 5Placebo comparator22 subjects to receive placebo to match GS-9450 for 4 weeks
Receives: Drug: GS-9450 Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities

    Measured: Baseline to Post-treatment Week 24

Secondary outcomes (2)

  1. Pharmacokinetics of GS-9450 and its metabolites

    Pharmacokinetics (Cmax, Tmax, Cmin, λz, t1/2, AUCtau, Vdss/F, and CL/F) measured by plasma sampling

    Measured: Weeks 2 and 4

  2. Change from baseline in alanine aminotransferase (ALT)

    Measured: Baseline to Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionAug 2009
  4. Study completionSep 2009

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00740610
Sponsor's protocol ID
GS-US-228-0101
Status last verified
Jan 2014
First submitted
21 Aug 2008
Last updated
4 Feb 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GS-9450 in people with Nonalcoholic Steatohepatitis, run by Gilead Sciences at 33 sites in 2 countries.

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 10 inclusion and 20 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 4 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 33 sites in United States, France. 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. Some participants in this study may receive a placebo. 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?

Percentage of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities (time frame: Baseline to Post-treatment Week 24). 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 NCT00740610.

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 4 Feb 2014.

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