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Study of INT-747 as Monotherapy in Patients With PBC

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ClinicalTrials.gov Identifier: NCT00570765
Recruitment Status : Completed
First Posted : December 11, 2007
Results First Posted : July 7, 2011
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
Intercept Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE December 7, 2007
First Posted Date  ICMJE December 11, 2007
Results First Submitted Date  ICMJE June 9, 2011
Results First Posted Date  ICMJE July 7, 2011
Last Update Posted Date April 3, 2018
Study Start Date  ICMJE November 2007
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2012)
Alkaline Phosphatase (AP) Levels [ Time Frame: Baseline and 12 weeks ]
Percent (%) Change in Serum Alkaline Phosphatase from baseline to end of study (EOS)at Day 85.
Original Primary Outcome Measures  ICMJE
 (submitted: December 7, 2007)
In patients with primary biliary cirrhosis (PBC), to assess the effects of INT-747 on both 1) alkaline phosphatase (AP) levels and 2) safety [ Time Frame: 12 weeks ]
Change History Complete list of historical versions of study NCT00570765 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2012)
  • Hepatocellular Injury and Liver Function: GGT [ Time Frame: Baeline and 12 weeks ]
    Percent change of gamma-glutamyl transferase (GGT)from Baseline (Day 0) vs. Day 85/ or early termination (ET) visit.
  • Hepatocellular Injury and Liver Function: ALT [ Time Frame: Baeline and 12 weeks ]
    Percent change of alanine transaminase(ALT)from Baseline (Day 0) vs. Day 85/ or early termination.
  • Plasma Trough Concentrations of INT-747 and Its Major, Known Metabolites [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2007)
  • In patients with primary biliary cirrhosis (PBC), to assess the effects of INT-747 on 1) hepatocellular injury and liver function, 2) disease-specific and general health symptoms and 3) biomarkers of hepatic inflammation and fibrosis. [ Time Frame: 12 weeks ]
  • Plasma Trough Concentrations of INT-747 and Its Major, Known Metabolites [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of INT-747 as Monotherapy in Patients With PBC
Official Title  ICMJE A Study of INT-747 (6-ECDCA) Monotherapy in Patients With Primary Biliary Cirrhosis
Brief Summary The primary hypothesis is that INT 747 will cause a reduction in alkaline phosphatase levels in PBC patients, over a 12 week treatment period, as compared to placebo.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Liver Cirrhosis, Biliary
Intervention  ICMJE
  • Drug: Placebo
    Placebo
  • Drug: INT-747
    10 mg po qd
  • Drug: INT-747
    50 mg po qd
Study Arms  ICMJE
  • Experimental: 10 mg PO QD
    Intervention: Drug: INT-747
  • Experimental: 50 mg PO QD
    Intervention: Drug: INT-747
  • Placebo Comparator: Placebo PO QD
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 9, 2011)
59
Original Estimated Enrollment  ICMJE
 (submitted: December 7, 2007)
120
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female age 18 to 70 years.
  • Female patients must be postmenopausal, surgically sterile, or prepared to use 2 methods of contraception with all sexual partners during the study and for 14 days after the end of dosing.
  • Male patients must be prepared to use 2 methods of contraception with all sexual partners during the study and for 14 days after the end of the dosing.
  • Proven or likely PBC, as demonstrated by the patient presenting with at least 2 of the following 3 diagnostic factors:
  • History of increased AP levels for at least 6 months prior to Day 0
  • Positive AMA titer (>1:40 titer on immunofluorescence or M2 positive by ELISA) or PBC-specific antinuclear antibodies (antinuclear dot and nuclear rim positive)
  • Liver biopsy consistent with PBC
  • Screening AP value between 1.5 and 10 × ULN

Exclusion Criteria:

  • Administration of the following drugs at any time during the 3 months prior to screening for the study: ursodeoxycholic acid (UDCA, URSO®), colchicine, methotrexate, azathioprine, or systemic corticosteroids.
  • Screening conjugated (direct) bilirubin >2 × ULN.
  • Screening ALT or AST >5 × ULN.
  • Screening serum creatinine >133 μmol/L (1.5 mg/dL). History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy, or poorly controlled ascites).
  • History or presence of other concomitant liver diseases including hepatitis due to hepatitis B or C virus (HCV, HBV) infection, primary sclerosing cholangitis (PSC), alcoholic liver disease, definite autoimmune liver disease or biopsy proven nonalcoholic steatohepatitis (NASH).
  • Pregnancy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Canada,   France,   Germany,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00570765
Other Study ID Numbers  ICMJE 747-201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Intercept Pharmaceuticals
Study Sponsor  ICMJE Intercept Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: David A Shapiro, MD Intercept Pharmaceuticals
PRS Account Intercept Pharmaceuticals
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP