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Effect of Isoniazid on Protoporphyrin Levels in Erythropoietic Protoporphyria (INHEPP)

This study has been terminated.
(Interim analysis demonstrated the treatment was not effective)
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Icahn School of Medicine at Mount Sinai
University of Alabama at Birmingham
University of California, San Francisco
University of Texas
Information provided by (Responsible Party):
John Phillips, University of Utah
ClinicalTrials.gov Identifier:
NCT01550705
First received: March 5, 2012
Last updated: November 19, 2016
Last verified: November 2016
Results First Received: November 19, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Erythropoietic Protoporphyria (EPP)
X Linked Erythropoietic Protoporphyria
Intervention: Drug: Isoniazid

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Isoniazid

Subjects will receive isoniazid daily for 2 months. Subjects will be seen every 2 weeks to obtain lab samples and health check.

Isoniazid: Isoniazid 5 mg/Kg up to 300 mg per day. Oral tablets. 2 months.


Participant Flow:   Overall Study
    Isoniazid
STARTED   11 
COMPLETED   10 
NOT COMPLETED   1 



  Baseline Characteristics
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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
Isoniazid

Subjects will receive isoniazid daily for 2 months. Subjects will be seen every 2 weeks to obtain lab samples and health check.

Isoniazid: Isoniazid 5 mg/Kg up to 300 mg per day. Oral tablets. 2 months.


Baseline Measures
   Isoniazid 
Overall Participants Analyzed 
[Units: Participants]
 11 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      11 100.0% 
>=65 years      0   0.0% 
Gender 
[Units: Participants]
Count of Participants
 
Female      6  54.5% 
Male      5  45.5% 
Protoporphyria Type 
[Units: Participants]
Count of Participants
 
Erythropoietic Protoporphyria (EPP)      9  81.8% 
X-linked Erythropoietic Protoporphyria (XLEPP)      2  18.2% 
Baseline Protoporphyrin IX level 
[Units: Micrograms per deciliter (µg/dL)]
Mean (Standard Deviation)
 13.3  (14.4) 


  Outcome Measures
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1.  Primary:   Change in Plasma Protoporphyrin IX Level   [ Time Frame: Baseline and 3 Months ]

2.  Secondary:   Participants With Increased Sun Sensitivity   [ Time Frame: Baseline and 3 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: John D. Phillips, Ph.D.
Organization: University of Utah
phone: 801-581-6650
e-mail: john.phillips@hsc.utah.edu



Responsible Party: John Phillips, University of Utah
ClinicalTrials.gov Identifier: NCT01550705     History of Changes
Other Study ID Numbers: UTINH
U54DK083909 ( U.S. NIH Grant/Contract )
Study First Received: March 5, 2012
Results First Received: November 19, 2016
Last Updated: November 19, 2016