Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Chronic Delta Hepatitis With Lonafarnib, Ritonavir and Lambda Interferon

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: NCT03600714
Recruitment Status : Completed
First Posted : July 26, 2018
Results First Posted : December 1, 2021
Last Update Posted : December 14, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Liver Disease
Hepatitis D
Interventions Drug: Peg-interferon lambda
Drug: Lonafarnib
Drug: Ritonavir
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment
Hide Arm/Group Description Patients were treated with lonafarnib 50 mg orally twice daily, ritonavir 100 mg orally twice daily and lambda 180 mcg subcutaneously weekly for 24 weeks
Period Title: Overall Study
Started 26
Completed 25
Not Completed 1
Reason Not Completed
Out of country and could not return for post-treatment visits             1
Arm/Group Title Treatment
Hide Arm/Group Description Treatment with Lonafarnib, Ritonavir, and Peginterferon lambda
Overall Number of Baseline Participants 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants
42  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Female
10
  38.5%
Male
16
  61.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
25
  96.2%
Unknown or Not Reported
1
   3.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
American Indian or Alaska Native
0
   0.0%
Asian
14
  53.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
  15.4%
White
8
  30.8%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants
26
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 26 participants
27.3  (8.9)
1.Primary Outcome
Title Number of Participants With Decline of Hepatitis D Virus (HDV) RNA Viral Titer of >2 Logs
Hide Description Decline of HDV RNA viral titer of >2 logs from baseline at 24 weeks of therapy
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Three participants who discontinued treatment before 24 weeks did not have HDV RNA measured at 24 weeks. They were seen at post-treatment visits
Arm/Group Title Treatment
Hide Arm/Group Description:
Treatment with Lonafarnib, Ritonavir, and Peginterferon lambda
Overall Number of Participants Analyzed 23
Measure Type: Count of Participants
Unit of Measure: Participants
18
  78.3%
2.Primary Outcome
Title Number of Participants Who Discontinue Medication
Hide Description Discontinuation of the medication before 24 weeks by the clinical team or patient will be considered a failure to tolerate the medicine.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment
Hide Arm/Group Description:
Treatment with Lonafarnib, Ritonavir, and Peginterferon lambda
Overall Number of Participants Analyzed 26
Measure Type: Count of Participants
Unit of Measure: Participants
3
  11.5%
3.Secondary Outcome
Title Number of Participants With Sustained Virologic Response
Hide Description Undetectable HDV RNA at both 12 and 24 weeks post treatment follow-up visits
Time Frame 12 and 24 weeks after completing therapy
Hide Outcome Measure Data
Hide Analysis Population Description
25 participants had data at 24 weeks post treatment
Arm/Group Title Treatment
Hide Arm/Group Description:
Treatment with Lonafarnib, Ritonavir, and Peginterferon lambda
Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
3
  12.0%
4.Secondary Outcome
Title Number of Participants With Reduction in Histologic Inflammatory Scores (Modified HAI)
Hide Description Reduction in histologic inflammatory scores (modified HAI) by at least two points with no progression in histologic fibrosis (Ishak) at week 24 post-treatment follow-up.
Time Frame End of treatment and 24 weeks after completing therapy.
Hide Outcome Measure Data
Hide Analysis Population Description
21 participants had liver biopsies at 24 weeks post treatment
Arm/Group Title Treatment
Hide Arm/Group Description:
Treatment with Lonafarnib, Ritonavir, and Peginterferon lambda
Overall Number of Participants Analyzed 21
Measure Type: Count of Participants
Unit of Measure: Participants
6
  28.6%
5.Secondary Outcome
Title Number of Participants With Normalization of Serum ALT
Hide Description Normalization of serum ALT (ALT <20 in females and ALT <31 in males) at the end of therapy, at week 12 of posttherapy follow-up and at week 24 of post-therapy follow-up, OR reduction in serum ALT by >50% of baseline at week 12 of post therapy follow up and week 24 of post therapy follow up.
Time Frame End of therapy, and 12 and 24 weeks after completing therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Two participants did not have ALT measures at 12 weeks post treatment
Arm/Group Title Treatment
Hide Arm/Group Description:
Treatment with Lonafarnib, Ritonavir, and Peginterferon lambda
Overall Number of Participants Analyzed 24
Measure Type: Count of Participants
Unit of Measure: Participants
2
   8.3%
6.Secondary Outcome
Title Number of Participants With Reduction of Hepatic Venous Pressure Gradient (HVPG)
Hide Description Reduction in hepatic venous pressure gradient (HVPG) measurements by >25% of baseline OR normalization of HVPG (<5 mm Hg) at 24 weeks after completing therapy
Time Frame Baseline and 24 weeks after completing therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Five participant did not have HVPG measured at 24 weeks post treatment
Arm/Group Title Treatment
Hide Arm/Group Description:
Treatment with Lonafarnib, Ritonavir, and Peginterferon lambda
Overall Number of Participants Analyzed 21
Measure Type: Count of Participants
Unit of Measure: Participants
10
  47.6%
7.Secondary Outcome
Title Number of Participants With Reduction in Fibroscan Transient Elastography Values
Hide Description Reduction in Fibroscan transient elastography values by >25% of baseline at end of therapy.
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only 13 participants had Fibroscans at baseline and 24 weeks
Arm/Group Title Treatment
Hide Arm/Group Description:
Treatment with Lonafarnib, Ritonavir, and Peginterferon lambda
Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
4
  30.8%
8.Secondary Outcome
Title Number of Participants With Loss of HBsAg at Week 24
Hide Description Loss of HBsAg from the serum at week 24
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
22 participants had HBsAg values at week 24
Arm/Group Title Treatment
Hide Arm/Group Description:
Treatment with Lonafarnib, Ritonavir, and Peginterferon lambda
Overall Number of Participants Analyzed 22
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
9.Secondary Outcome
Title Number of Participants With Loss of HBsAg at Week 12 Weeks After Completing Therapy
Hide Description Loss of HBsAg from the serum at 12 weeks after completing therapy
Time Frame 12 weeks after completing therapy
Hide Outcome Measure Data
Hide Analysis Population Description
24 participants had HBsAg measurements at 12 weeks after the end of treatment
Arm/Group Title Treatment
Hide Arm/Group Description:
Treatment with Lonafarnib, Ritonavir, and Peginterferon lambda
Overall Number of Participants Analyzed 24
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
10.Secondary Outcome
Title Number of Participants With Loss of HBsAg at 24 Weeks After Completing Therapy
Hide Description Loss of HBsAg from the serum at 24 weeks after completing therapy
Time Frame 24 weeks after completing therapy
Hide Outcome Measure Data
Hide Analysis Population Description
24 participants had HBsAg measurements at 24 weeks after the end of treatment
Arm/Group Title Treatment
Hide Arm/Group Description:
Treatment with Lonafarnib, Ritonavir, and Peginterferon lambda
Overall Number of Participants Analyzed 24
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
11.Secondary Outcome
Title Change in Quantitative Log HBsAg Levels From Baseline to Week 24
Hide Description Change in quantitative log HBsAg levels at from baseline to week 24
Time Frame Baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
22 participants had HBsAg values at week 24
Arm/Group Title Treatment
Hide Arm/Group Description:
Treatment with Lonafarnib, Ritonavir, and Peginterferon lambda
Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: log IU/mL
0.15  (0.22)
12.Secondary Outcome
Title Change in Quantitative Log HBsAg Levels From Baseline 24 Weeks After Completing Therapy
Hide Description Change in quantitative log HBsAg levels at from baseline to 24 weeks after completing therapy
Time Frame Baseline and 24 weeks after completing therapy
Hide Outcome Measure Data
Hide Analysis Population Description
24 participants had HBsAg measurements at 24 weeks after the end of treatment
Arm/Group Title Treatment
Hide Arm/Group Description:
Treatment with Lonafarnib, Ritonavir, and Peginterferon lambda
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: log IU/mL
0.16  (0.19)
Time Frame 48 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment
Hide Arm/Group Description Treatment with Lonafarnib, Ritonavir, and Peginterferon lambda
All-Cause Mortality
Treatment
Affected / at Risk (%)
Total   0/26 (0.00%) 
Hide Serious Adverse Events
Treatment
Affected / at Risk (%)
Total   0/26 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Treatment
Affected / at Risk (%)
Total   24/26 (92.31%) 
Blood and lymphatic system disorders   
Anemia   2/26 (7.69%) 
Gastrointestinal disorders   
Nausea   18/26 (69.23%) 
Diarrhea   21/26 (80.77%) 
GERD   15/26 (57.69%) 
Hepatobiliary disorders   
Hyperbilirubinemia   6/26 (23.08%) 
Ascites   1/26 (3.85%) 
Investigations   
Weight Loss   6/26 (23.08%) 
Metabolism and nutrition disorders   
Decreased Appetite   13/26 (50.00%) 
Hypokalemia   1/26 (3.85%) 
Musculoskeletal and connective tissue disorders   
Fatigue   8/26 (30.77%) 
Nervous system disorders   
Headache   1/26 (3.85%) 
Insomnia   2/26 (7.69%) 
Skin and subcutaneous tissue disorders   
Acneiform Rash   4/26 (15.38%) 
Hair Loss   2/26 (7.69%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Christopher Koh
Organization: NIDDK
Phone: 301-443-9402
EMail: kohchris@mail.nih.gov
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
ClinicalTrials.gov Identifier: NCT03600714    
Other Study ID Numbers: 180123
18-DK-0123 ( Other Identifier: NIH Clinical Center )
First Submitted: July 25, 2018
First Posted: July 26, 2018
Results First Submitted: November 2, 2021
Results First Posted: December 1, 2021
Last Update Posted: December 14, 2021