Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 94 for:    Primary Sclerosing Cholangitis

PERSEUS: Preliminary Efficacy and Safety of Cenicriviroc in Adult Participants With Primary Sclerosing Cholangitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02653625
Recruitment Status : Completed
First Posted : January 12, 2016
Results First Posted : October 1, 2018
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
Tobira Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE January 8, 2016
First Posted Date  ICMJE January 12, 2016
Results First Submitted Date  ICMJE August 31, 2018
Results First Posted Date  ICMJE October 1, 2018
Last Update Posted Date October 1, 2018
Actual Study Start Date  ICMJE March 14, 2016
Actual Primary Completion Date August 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2018)
Percentage Change From Baseline Through Week 24 in Serum Alkaline Phosphatase (ALP) [ Time Frame: Baseline (Day 1) to Week 24 ]
ALP was used as a primary surrogate marker for measuring Primary Sclerosing Cholangitis disease. The percent change from Baseline was defined as 100*(value at each visit - Baseline value)/Baseline value. The Baseline value was defined as the last non-missing value on or before the Baseline visit (Day 1). A negative percentage change from baseline indicates an improvement.
Original Primary Outcome Measures  ICMJE
 (submitted: January 8, 2016)
Percent change from baseline through Week 24 in serum alkaline phosphatase [ Time Frame: 24 weeks ]
Change History Complete list of historical versions of study NCT02653625 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2018)
  • Percentage of Participants Who Normalized ALP at Week 24 [ Time Frame: Week 24 ]
    ALP was used as a primary surrogate marker for measuring Primary Sclerosing Cholangitis disease. Normalization was defined as ALP values outside of the central laboratory reference range at baseline, but within the central laboratory reference range at Week 24.
  • Percentage of Participants Who Achieved Serum ALP of Less Than 1.5 Times Upper Limit of Normal (ULN) in Serum ALP at Week 24 [ Time Frame: Week 24 ]
    ALP was used as a primary surrogate marker for measuring Primary Sclerosing Cholangitis disease. The upper limit of normal ALP was defined according to the central laboratory reference ranges.
  • Percentage of Participants Who Achieved a 50% Decrease in ALP at Week 24 [ Time Frame: Week 24 ]
    ALP was used as a primary surrogate marker for measuring Primary Sclerosing Cholangitis disease.
  • Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) [ Time Frame: Baseline (Day 1) to Week 24 ]
    An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, regardless of whether related to the medicinal (investigational) product. A TEAE was defined as an AE with an onset that occurred after receiving treatment.
  • Percentage of Participants Who Discontinued Due to a TEAE [ Time Frame: Baseline (Day 1) to Week 24 ]
    An adverse event was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, regardless of whether related to the medicinal (investigational) product. A TEAE was defined as an AE with an onset that occurred after receiving treatment.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: January 8, 2016)
Proportion of subjects with treatment-emergent adverse event [ Time Frame: 24 weeks ]
 
Descriptive Information
Brief Title  ICMJE PERSEUS: Preliminary Efficacy and Safety of Cenicriviroc in Adult Participants With Primary Sclerosing Cholangitis
Official Title  ICMJE PERSEUS: A Phase 2 Proof of Concept Study Investigating the Preliminary Efficacy and Safety of Cenicriviroc in Adult Subjects With Primary Sclerosing Cholangitis (PSC)
Brief Summary This is an open label, proof of concept (PoC) study of Cenicriviroc (CVC) in adult participants with Primary Sclerosing Cholangitis (PSC). The main objective of this PoC study is to assess changes in alkaline phosphatase (ALP) both individually and as a group, over 24 weeks of treatment with CVC.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Primary Sclerosing Cholangitis
Intervention  ICMJE Drug: Cenicriviroc 150 mg
One tablet of CVC 150 mg once daily taken with food in the morning.
Other Name: CVC 150 mg
Study Arms  ICMJE Experimental: Cenicriviroc 150 mg
One tablet of Cenicriviroc 150 mg once daily with food in the morning for 24 weeks.
Intervention: Drug: Cenicriviroc 150 mg
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 20, 2017)
24
Original Estimated Enrollment  ICMJE
 (submitted: January 8, 2016)
25
Actual Study Completion Date  ICMJE August 31, 2017
Actual Primary Completion Date August 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants with chronic cholestatic liver disease for at least 6 months
  • Clinical diagnosis of Primary Sclerosing Cholangitis (PSC) as evident by chronic cholestasis of more than six months duration with either a consistent magnetic resonance cholangiopancreatography (MRCP)/endoscopic retrograde cholangiopancreatography (ERCP) showing sclerosing cholangitis, or a liver biopsy taken at any time consistent with PSC in the absence of a documented alternative etiology for sclerosing cholangitis. If diagnosis of PSC was made by histology alone, it must require the presence of fibro-obliterative lesions (i.e., onion skin lesions)
  • Participants with or without Inflammatory Bowel Disease (IBD) are allowed. If participant has IBD, documented evidence of IBD either by prior endoscopy or in previous medical records, for ≥ 6 months. In addition, participants will be required to enter the study with a Partial Mayo Risk score of 0-3, inclusively
  • In participants receiving treatment with ursodeoxycholic acid (UDCA), therapy must be stable for at least 3 months, and at a dose not greater than 20 mg/kg/day
  • Serum ALP greater than 1.5 × upper limit of normal (ULN)
  • Ability to understand and sign a written informed consent form (ICF)
  • Participants receiving allowed concomitant medications need to be on stable therapy for 28 days prior to the Baseline Visit with the exception of UDCA in which participants need to be on stable therapy for ≥ 3 months

Exclusion Criteria:

  • Presence of documented secondary sclerosing cholangitis (such as ischemic cholangitis, recurrent pancreatitis, intraductal stone disease, severe bacterial cholangitis, surgical or blunt abdominal trauma, recurrent pyogenic cholangitis, choledocholithiasis, toxic sclerosing cholangitis due to chemical agents, or any other cause of secondary sclerosing cholangitis) on prior clinical investigations
  • Small duct PSC
  • Presence of percutaneous drain or bile duct stent
  • History of cholangiocarcinoma or high clinical suspicion over dominant stricture within 1 year by MRCP/ERCP or clinical judgment
  • Ascending cholangitis within 60 days prior to Screening
  • Alcohol consumption greater than 21 units/week for males or 14 units/week for females (one unit of alcohol is ½ pint of beer [285 mL], 1 glass of spirits [25 mL] or 1 glass of wine [125 mL])
  • Prior or planned liver transplantation
  • Presence of alternative causes of chronic liver disease, including alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, autoimmune hepatitis
  • History of cirrhosis and/or hepatic impairment (Child-Pugh classes A, B and C) and/or hepatic decompensation including ascites, encephalopathy or variceal bleeding. Participants who show evidence of significant worsening of hepatic function will be excluded
  • Participants with fibrosis evidence of cirrhosis, as determined by local transient elastography (TE, e.g., Fibroscan) values of ≥ 13.0 kPa, taken within the last 6 months. If TE has not been conducted within the 6 months prior to screening, then one will be conducted during the screening period and can be used as the Baseline value.
  • Moderate to Severe active IBD or flare in colitis activity within the last 90 days requiring intensification of therapy beyond Baseline treatment. Participants with stable mild to moderate IBD, who are on treatment, are allowed provided they are stable for 3 months with 5-amino salicylic acid drugs or Azathioprine (allowed dose of azathioprine is 50-200 mg/day)
  • Use of oral prednisolone > 10 mg/day, biologics and/or hospitalization for colitis within 90 days are disallowed
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT); above the allowed cut-offs, as determined by Screening values:

    • AST > 200 IU/L males and females
    • ALT: males > 250 IU/L and females > 200 IU/L
  • Total Bilirubin and Direct Bilirubin; above the allowed cut-offs, as determined by Screening values:

    • Total Bilirubin > 2.0 mg/dL
    • Direct Bilirubin > 0.8 mg/dL
  • International normalized ratio > 1.3 in the absence of anticoagulants
  • Immunoglobulin G4 (IgG4) > 4 × ULN at Screening or evidence of IgG4-related sclerosing cholangitis
  • Females who are pregnant or breastfeeding
  • Any other clinically significant disorders or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with the dosing and protocol requirements
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 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 Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02653625
Other Study ID Numbers  ICMJE 652-205
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tobira Therapeutics, Inc.
Study Sponsor  ICMJE Tobira Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: J.P. Nicandro Allergan
PRS Account Tobira Therapeutics, Inc.
Verification Date August 2018

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