Trial Outcomes & Findings for Combination Treatment With REP 2139-Ca and Pegasys in Patients With Chronic Hepatitis B (NCT NCT02726789)
NCT ID: NCT02726789
Last Updated: 2019-05-08
Results Overview
To record side effects, symptoms and adverse effects of exposure to REP 2139-Ca when combined pegylated interferon.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
48 weeks (treatment)
Results posted on
2019-05-08
Participant Flow
Participant milestones
| Measure |
Experimental
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.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combination Treatment With REP 2139-Ca and Pegasys in Patients With Chronic Hepatitis B
Baseline characteristics by cohort
| Measure |
Experimental
n=5 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
27.6 years
STANDARD_DEVIATION 3.14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Bangladesh
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 weeks (treatment)To record side effects, symptoms and adverse effects of exposure to REP 2139-Ca when combined pegylated interferon.
Outcome measures
| Measure |
Experimental
n=5 Participants
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.
|
|---|---|
|
Number of Patients Experiencing Treatment Emergent Laboratory Test Abnormalities or Adverse Events.
|
5 Participants
|
SECONDARY outcome
Timeframe: 48 weeks (treatment)To assess antiviral activity of REP 2139-Ca when combined with pegylated interferon on serum HBsAg.
Outcome measures
| Measure |
Experimental
n=5 Participants
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.
|
|---|---|
|
Number of Patients Experiencing Reductions in Serum HBsAg
|
5 Participants
|
SECONDARY outcome
Timeframe: 48 weeks (treatment)To assess antiviral activity of REP 2139-Ca when combined with pegylated interferon on serum HBV DNA.
Outcome measures
| Measure |
Experimental
n=5 Participants
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.
|
|---|---|
|
Number of Patients Experiencing Reductions in Serum HBV DNA
|
5 Participants
|
SECONDARY outcome
Timeframe: 48 weeks (treatment)To assess antiviral activity of REP 2139-Ca when combined with pegylated interferon on anti-HBsAg antibody titer.
Outcome measures
| Measure |
Experimental
n=5 Participants
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.
|
|---|---|
|
Number of Patients Experiencing Serum Anti-HBs > 10 mIU / ml
|
5 Participants
|
Adverse Events
Experimental
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental
n=5 participants at risk
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.
|
|---|---|
|
Renal and urinary disorders
Nephrotic syndrome
|
20.0%
1/5 • Number of events 1 • 3 years
Weekly patient surveillance during therapy, every 1-8 weeks during follow-up
|
Other adverse events
| Measure |
Experimental
n=5 participants at risk
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.
|
|---|---|
|
Hepatobiliary disorders
ALT elevation
|
100.0%
5/5 • Number of events 5 • 3 years
Weekly patient surveillance during therapy, every 1-8 weeks during follow-up
|
|
General disorders
Weakness
|
100.0%
5/5 • Number of events 23 • 3 years
Weekly patient surveillance during therapy, every 1-8 weeks during follow-up
|
|
General disorders
Reduced appetite
|
100.0%
5/5 • Number of events 21 • 3 years
Weekly patient surveillance during therapy, every 1-8 weeks during follow-up
|
|
General disorders
Hairloss
|
100.0%
5/5 • Number of events 13 • 3 years
Weekly patient surveillance during therapy, every 1-8 weeks during follow-up
|
|
Gastrointestinal disorders
Nausea
|
100.0%
5/5 • Number of events 8 • 3 years
Weekly patient surveillance during therapy, every 1-8 weeks during follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Asthenia
|
40.0%
2/5 • Number of events 5 • 3 years
Weekly patient surveillance during therapy, every 1-8 weeks during follow-up
|
|
Gastrointestinal disorders
Abdominal cramping
|
80.0%
4/5 • Number of events 4 • 3 years
Weekly patient surveillance during therapy, every 1-8 weeks during follow-up
|
|
Gastrointestinal disorders
Dysphagia
|
100.0%
5/5 • Number of events 5 • 3 years
Weekly patient surveillance during therapy, every 1-8 weeks during follow-up
|
|
Gastrointestinal disorders
Dusgeusia
|
100.0%
5/5 • Number of events 9 • 3 years
Weekly patient surveillance during therapy, every 1-8 weeks during follow-up
|
|
Cardiac disorders
Chest pain
|
40.0%
2/5 • Number of events 2 • 3 years
Weekly patient surveillance during therapy, every 1-8 weeks during follow-up
|
|
Nervous system disorders
Pain / tingling in periphery
|
100.0%
5/5 • Number of events 11 • 3 years
Weekly patient surveillance during therapy, every 1-8 weeks during follow-up
|
|
General disorders
Fever
|
60.0%
3/5 • Number of events 6 • 3 years
Weekly patient surveillance during therapy, every 1-8 weeks during follow-up
|
|
General disorders
Generalized body ache
|
40.0%
2/5 • Number of events 5 • 3 years
Weekly patient surveillance during therapy, every 1-8 weeks during follow-up
|
|
General disorders
Weight loss
|
100.0%
5/5 • Number of events 8 • 3 years
Weekly patient surveillance during therapy, every 1-8 weeks during follow-up
|
|
Hepatobiliary disorders
AST elevation
|
100.0%
5/5 • Number of events 5 • 3 years
Weekly patient surveillance during therapy, every 1-8 weeks during follow-up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place