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Combination Treatment With REP 2139-Ca and Pegasys in Patients With Chronic Hepatitis B

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ClinicalTrials.gov Identifier: NCT02726789
Recruitment Status : Completed
First Posted : April 4, 2016
Results First Posted : May 8, 2019
Last Update Posted : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
Replicor Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis B, Chronic
Interventions Drug: REP 2139-Ca
Drug: pegylated interferon
Drug: entecavir
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Experimental
Hide Arm/Group Description Patients to receive REP 2139-Ca in combination with pegylated interferon. Participants included in this study are either entecavir naive OR have prior exposure to entecavir.
Period Title: Overall Study
Started 5
Completed 5
Not Completed 0
Arm/Group Title Experimental
Hide Arm/Group Description

Participants receive REP 2139-Ca in combination with pegylated interferon. Participants included in this study are either entecavir naive OR have prior exposure to entecavir.

REP 2139-Ca: the nucleic acid polymer REP 2139 formulated as a calcium chelate complex

pegylated interferon: immunotherapy

Participants receiving entecavir at the start of therapy continue to receive entecavir during experimental therapy.

Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants
27.6  (3.14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
1
  20.0%
Male
4
  80.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Bangladesh Number Analyzed 5 participants
5
1.Primary Outcome
Title Number of Patients Experiencing Treatment Emergent Laboratory Test Abnormalities or Adverse Events.
Hide Description To record side effects, symptoms and adverse effects of exposure to REP 2139-Ca when combined pegylated interferon.
Time Frame 48 weeks (treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental
Hide Arm/Group Description:

Participants receive REP 2139-Ca in combination with pegylated interferon. Participants included in this study are either entecavir naive OR have prior exposure to entecavir.

REP 2139-Ca: the nucleic acid polymer REP 2139 formulated as a calcium chelate complex

pegylated interferon: immunotherapy

Participants receiving entecavir at the start of experimental therapy continue to receive entecavir throughout experimental therapy.

Overall Number of Participants Analyzed 5
Measure Type: Count of Participants
Unit of Measure: Participants
5
 100.0%
2.Secondary Outcome
Title Number of Patients Experiencing Reductions in Serum HBsAg
Hide Description To assess antiviral activity of REP 2139-Ca when combined with pegylated interferon on serum HBsAg.
Time Frame 48 weeks (treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental
Hide Arm/Group Description:

Participants receive REP 2139-Ca in combination with pegylated interferon. Participants included in this study are either entecavir naive OR have prior exposure to entecavir.

REP 2139-Ca: the nucleic acid polymer REP 2139 formulated as a calcium chelate complex

pegylated interferon: immunotherapy

Partiipants receiving entecavir at the start of experimental therapy continue to receive entecavir throughout experimental therapy.

Overall Number of Participants Analyzed 5
Measure Type: Count of Participants
Unit of Measure: Participants
5
 100.0%
3.Secondary Outcome
Title Number of Patients Experiencing Reductions in Serum HBV DNA
Hide Description To assess antiviral activity of REP 2139-Ca when combined with pegylated interferon on serum HBV DNA.
Time Frame 48 weeks (treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental
Hide Arm/Group Description:

Participants receive REP 2139-Ca in combination with pegylated interferon. Participants included in this study are either entecavir naive OR have prior exposure to entecavir.

REP 2139-Ca: the nucleic acid polymer REP 2139 formulated as a calcium chelate complex

pegylated interferon: immunotherapy

Participants receiving entecavir at the start of experimental therapy continue to receive entecavir throughout experimental therapy.

Overall Number of Participants Analyzed 5
Measure Type: Count of Participants
Unit of Measure: Participants
5
 100.0%
4.Secondary Outcome
Title Number of Patients Experiencing Serum Anti-HBs > 10 mIU / ml
Hide Description To assess antiviral activity of REP 2139-Ca when combined with pegylated interferon on anti-HBsAg antibody titer.
Time Frame 48 weeks (treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental
Hide Arm/Group Description:

Participants receive REP 2139-Ca in combination with pegylated interferon. Participants included in this study are either entecavir naive OR have prior exposure to entecavir.

REP 2139-Ca: the nucleic acid polymer REP 2139 formulated as a calcium chelate complex

pegylated interferon: immunotherapy

Participants receiving entecavir at the start of experimental therapy continue to receive entecavir throughout experimental therapy.

Overall Number of Participants Analyzed 5
Measure Type: Count of Participants
Unit of Measure: Participants
5
 100.0%
Time Frame 3 years
Adverse Event Reporting Description Weekly patient surveillance during therapy, every 1-8 weeks during follow-up
 
Arm/Group Title Experimental
Hide Arm/Group Description

Participants receive REP 2139-Ca in combination with pegylated interferon. Participants included in this study are either entecavir naive OR have prior exposure to entecavir.

REP 2139-Ca: the nucleic acid polymer REP 2139 formulated as a calcium chelate complex

pegylated interferon: immunotherapy

Participants receiving entecavir at the start of experimental therapy continue to receive entecavir throughout experimental therapy.

All-Cause Mortality
Experimental
Affected / at Risk (%)
Total   0/5 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Experimental
Affected / at Risk (%) # Events
Total   1/5 (20.00%)    
Renal and urinary disorders   
Nephrotic syndrome * [1]  1/5 (20.00%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Nephrotic syndrome occurred at week 38 exposure secondary to facial edema presence of urine albumin . Pegasys® therapy was halted early in this patient who recovered during the follow-up with supportive therapy
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Experimental
Affected / at Risk (%) # Events
Total   5/5 (100.00%)    
Cardiac disorders   
Chest pain *  2/5 (40.00%)  2
Gastrointestinal disorders   
Nausea *  5/5 (100.00%)  8
Abdominal cramping *  4/5 (80.00%)  4
Dysphagia *  5/5 (100.00%)  5
Dusgeusia *  5/5 (100.00%)  9
General disorders   
Weakness *  5/5 (100.00%)  23
Reduced appetite *  5/5 (100.00%)  21
Hairloss *  5/5 (100.00%)  13
Fever *  3/5 (60.00%)  6
Generalized body ache *  2/5 (40.00%)  5
Weight loss *  5/5 (100.00%)  8
Hepatobiliary disorders   
ALT elevation * [1]  5/5 (100.00%)  5
AST elevation * [2]  5/5 (100.00%)  5
Nervous system disorders   
Pain / tingling in periphery *  5/5 (100.00%)  11
Respiratory, thoracic and mediastinal disorders   
Asthenia *  2/5 (40.00%)  5
*
Indicates events were collected by non-systematic assessment
[1]
Transient, self resolving elevations in serum ALT not accompanied by elevation in bilirubin or INR.
[2]
Transient, self resolving elevations in serum AST not accompanied by elevation in bilirubin or INR.
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
Layout table for Results Point of Contact information
Name/Title: Chief Scientific Officer
Organization: Replicor Inc.
Phone: 514 733 1998
EMail: availlant@replicor.com
Layout table for additonal information
Responsible Party: Replicor Inc.
ClinicalTrials.gov Identifier: NCT02726789     History of Changes
Other Study ID Numbers: REP 201
First Submitted: March 18, 2016
First Posted: April 4, 2016
Results First Submitted: August 27, 2018
Results First Posted: May 8, 2019
Last Update Posted: May 8, 2019