Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Pilot Study of Effect of Sorafenib on Portal Pressure

This study has been completed.
Sponsor:
Collaborator:
Onyx Therapeutics, Inc.
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01714609
First received: October 23, 2012
Last updated: November 3, 2015
Last verified: November 2015
Results First Received: November 3, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Clinically Significant Portal Hypertension
Interventions: Drug: Placebo
Drug: Sorafenib

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo

Subjects randomized to placebo will take two tablets of placebo by mouth twice daily.

Placebo: Placebo Comparator: Placebo

Sorafenib

Subjects randomized to Sorafenib will take Sorafenib 400 mg by mouth twice daily.

Sorafenib: Sorafenib, 400 mg twice daily


Participant Flow:   Overall Study
    Placebo     Sorafenib  
STARTED     5     5  
COMPLETED     4     5  
NOT COMPLETED     1     0  
Protocol Violation                 1                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo

Subjects randomized to placebo will take two tablets of placebo by mouth twice daily.

Placebo: Placebo Comparator: Placebo

Sorafenib

Subjects randomized to Sorafenib will take Sorafenib 400 mg by mouth twice daily.

Sorafenib: Sorafenib, 400 mg twice daily

Total Total of all reporting groups

Baseline Measures
    Placebo     Sorafenib     Total  
Number of Participants  
[units: participants]
  4     5     9  
Age  
[units: years]
Mean (Standard Deviation)
  55.98  (4.7)     58.78  (4.25)     57.38  (4.48)  
Gender  
[units: participants]
     
Female     0     0     0  
Male     4     5     9  
Region of Enrollment  
[units: participants]
     
United States     4     5     9  



  Outcome Measures

1.  Primary:   Patients With Change in HVPG From Baseline   [ Time Frame: Three Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Garcia-Tsao
Organization: Yale University
phone: (203) 737-6063
e-mail: guadalupe.garcia-tsao@yale.edu



Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01714609     History of Changes
Other Study ID Numbers: HIC # 1002006266
Study First Received: October 23, 2012
Results First Received: November 3, 2015
Last Updated: November 3, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration