Phase 2
Completed N=5
Combination Treatment With REP 2139-Ca and Pegasys in Patients With Chronic Hepatitis B
Hepatitis B, Chronic
Source: ClinicalTrials.gov NCT02726789 ↗
Enrolled (actual)
5
Serious AEs
20.0%
Results posted
May 2019
Primary outcomePrimary: Number of Patients Experiencing Treatment Emergent Laboratory Test Abnormalities or Adverse Events. — 5 Participants
Summary
The REP 201 protocol is a small exploratory study assessing the antiviral effects and tolerability of REP 2139-Ca when used with a full course of pegylated interferon (48 weeks) in treatment naive patients or in patients already receiving entecavir and continuing entecavir with treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Experiencing Treatment Emergent Laboratory Test Abnormalities or Adverse Events. |
5 | — |
| SECONDARY Number of Patients Experiencing Reductions in Serum HBsAg |
5 | — |
| SECONDARY Number of Patients Experiencing Reductions in Serum HBV DNA |
5 | — |
| SECONDARY Number of Patients Experiencing Serum Anti-HBs > 10 mIU / ml |
5 | — |
Eligibility Criteria
Inclusion Criteria
- Age between 18 and 55
- HBsAg+
- Anti-HBs negative
- Patients currently receiving nucleoside based HBV polymerase inhibitors may be included in the study at the discretion of the Principle Investigator.
- HIV / hepatitis C / hepatitis delta virus negative
- Fibrosis with compensation (as determined by Fibroscan and liver enzymes)
- Non cirrhotic
- No known active cytomegalovirus infection
- Willingness to utilize adequate contraception while being treated with REP 9AC' and for 6 months following the end of treatment
- Adequate venous access allowing weekly intravenous therapies and blood tests
Exclusion Criteria
- Evidence of cardiovascular disease
- Autoimmune hepatitis
- Presence of Wilson's disease
- Presence of severe NAFLD
- Evidence of any other co-existent liver disease
- Anti-nuclear antibody positive
- Ultrasonograph of hepato-biliary system: positive for cirrhosis of liver
- A history of ascites, hepatic encephalopathy or variceal hemorrhage
- Body weight > 100 kg
- Platelet count 100 ng/ml or the presence of a hepatic mass suggestive of hepatocellular carcinoma .
- Bilirubin > 2.5 mg/dl
- Creatinine > 1.5 mg/dl
- Platelet count < 75,000 / cmm
- Serum albumin < 35 mg/ml
- Poorly controlled diabetes mellitus
- Another serious medical disorder
- A serious psychiatric disorder
- Uncontrolled hypertension
- A history of alcohol abuse within the last year
- The use of illicit drugs within the past two years
- Inability to provide informed consent
- Positive pregnancy test
- Breastfeeding
- Inability or unwillingness to provide weekly blood samples
- Poor venous access making IV infusion too difficult
Data sourced from ClinicalTrials.gov (NCT02726789). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.