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Lonafarnib for Chronic Hepatitis D

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
ClinicalTrials.gov Identifier:
NCT01495585
First received: December 16, 2011
Last updated: July 18, 2016
Last verified: July 2016
History of Changes
Results First Received: April 28, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
Condition: Hepatitis D
Interventions: Drug: Lonafarnib
Other: Placebo

  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
In Group 1, participants were randomized either placebo or lonafarnib 100 mg. In Group2, participants were randomized into either placebo or lonafarnib 200 mg.

Reporting Groups
  Description
Placebo Two placebo participants in Group1 and two placebo participants in Group 2. The two placebo participants in Group 1 received open label lonafarnib 200 mg.
Lonafarnib 100 mg 6 participants were randomized to Lonafarnib 100 mg.
Lonafarnib 200 mg 4 participants were randomized to Lonafarnib 200 mg.

Participant Flow:   Overall Study
    Placebo     Lonafarnib 100 mg     Lonafarnib 200 mg  
STARTED     4     6     4  
Open Label Lonafarnib 200 mg     2     0     0  
COMPLETED     4     6     4  
NOT COMPLETED     0     0     0  



  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.

Enrolled patients were sequentially assigned into one of two dosing groups which consisted of lonafarnib 100mg in group 1 and lonafarnib 200mg in group 2, with placebo controls in each group.

Group1 placebo patients received open-label lonafarnib as group 2 participants.

Reporting Groups
  Description
Placebo placebo control.
Lonafarnib 100 mg 6 participants were randomized to Lonafarnib 100 mg.
Lonafarnib 200 mg 4 participants were randomized to Lonafarnib 200 mg and two "Placebo" participants in Lonafarnib 100 mg arm received open label lonafarnib 200 mg .
Total Total of all reporting groups

Baseline Measures
    Placebo     Lonafarnib 100 mg     Lonafarnib 200 mg     Total  
Number of Participants  
[units: participants]
 		  4     6     6     16  
Age  
[units: years]
Median (Inter-Quartile Range) 		  34  
  (33 to 39)   		  36  
  (30 to 42)   		  45  
  (38 to 55)   		  38  
  (33 to 48)  
Gender  
[units: participants]
 		       
Female     2     1     2     5  
Male     2     5     4     11  
Body mass index  
[units: kg/m^2]
Median (Inter-Quartile Range) 		  26.5  
  (24.1 to 28.9)   		  22.8  
  (21.9 to 23.5)   		  26.1  
  (25.5 to 27.3)   		  24.4  
  (21.9 to 27.3)  
Pre-treatment mucleoside analogues  
[units: participants]
 		       
yes     1     2     2     5  
no     3     4     4     11  
Ethnic origin  
[units: participants]
 		       
Asian     2     3     3     8  
White     1     3     3     7  
African     1     0     0     1  



  Outcome Measures
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1.  Primary:   Change in Quantitative Serum HDV RNA Levels After 28 Days of Lonafarnib Therapy.   [ Time Frame: 28 days ]
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2.  Secondary:   ALT Levels   [ Time Frame: 7 months ]
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  Serious Adverse Events
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  Other Adverse Events
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  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Theo Heller
Organization: National Insitute of DIabetes and Digestive and Kidney Diseases
phone: 301-402-7147
e-mail: hellert@mail.nih.gov


Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
ClinicalTrials.gov Identifier: NCT01495585     History of Changes
Other Study ID Numbers: 120046
12-DK-0046 ( Other Identifier: NIH Clinical Center )
Study First Received: December 16, 2011
Results First Received: April 28, 2016
Last Updated: July 18, 2016
Health Authority: United States: Federal Government
United States: Food and Drug Administration