Trial · Interventional

CompletedPhase 1/2Registry data

Therapeutic Safety and Efficacy of REP 2139 (REP 9AC') in HBV Infected Patients

NCTNCT02646189Other idREP 102

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1/2
Enrollment: 12 participants (actual)
Sponsor: Replicor Inc. · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
Bangladesh
Start: Aug 2011
Primary completion: Aug 2013
Completion: Aug 2013
First posted: 5 Jan 2016 (estimated)
Last update posted: 5 Jan 2016 (estimated)
Conditions: Hepatitis B, Chronic

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2011201220132014

Ph 1/2
Therapeutic Safety and Efficacy of REP 2139 (REP 9AC') in HBV Infected Patients
NCT02646189
Aug 2011 to Aug 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

REP 9AC (REP 2055) is a nucleic acid polymer (NAP) with entry and post-entry antiviral activity against duck hepatitis B virus (DHBV) infection. REP 2055 has been shown to have potent therapeutic effect against established DHBV infection in vivo REP 2055 was additionally shown to have significant antiviral effects in patients with chronic HBV infection in the previous REP 101 study. REP 2139 is a version of REP 2055 designed for improved administration tolerability and stability. The safety and antiviral activity REP 2139, first in monotherapy and then in combination with immunotherapy in patients with chronic HBV infection will be assessed in the REP 102 protocol.

Interventions

REP 2139-CaDrug
ZadaxinDrug
PegasysDrug

Arms1

Experimental
REP 2139-Ca + immunotherapy
REP 2139-Ca is the calcium chelate complex formulation of REP 2139. Zadaxin is thymosin alpha 1 Pegasys is pegylated interferon alpha 2a Patients initially receiving REP 2139-Ca with no Grade 3 adverse events at week 20 are eligible to transition to combination therapy with Zadaxin if serum HBV DNA is \> 2000 copies / ml. After 10 weeks of REP 2139-Ca / Zadaxin combination therapy, patients not experiencing a measurable improvement in serum antiviral response can further transition to combination therapy with REP 2139-Ca and Pegasys.

Primary outcomes1

Outcomes the sponsor listed as primary.

Safety and tolerability of REP 2139-Ca + immunotherapy
Time frame · 40 weeks (treatment)
Registry description
To record side effects, symptoms and adverse effects of exposure to REP 2139-Ca in monotherapy and when combined with Zadaxin and / or Pegasys.

Secondary outcomes(1)

Efficacy of REP 2139-Ca + immunotherapy
Time frame · 40 weeks (treatment) + 52 weeks (follow up)
Registry description
To assess antiviral activity of REP 2139-Ca in monotherapy and when combined with Zadaxin and / or Pegasus including serum HBsAg, HBeAg, anti-HBsAg antibodies, anti-HBeAg antibodies and HBV DNA.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies5

Studies that cite this trial.

Studies with results

5 studies on this page

Indexing hint: Clinical trial · 2016

4 results

Safety and Efficacy of Nucleic Acid Polymers in Monotherapy and Combined with Immunotherapy in Treatment-Naive Bangladeshi Patients with HBeAg+ Chronic Hepatitis B Infection.

Al-Mahtab et al. 2016PloS onecited by 144

PMID 27257978PMC4892580DOI 10.1371/journal.pone.0156667PUB-27257978

CC BY4 results

Download PDF See results (4)

Indexing hint: Randomized controlled trial · 2010

5 results

Effect of thymosin-α(1) on T-helper 1 cell and T-helper 2 cell cytokine synthesis in patients with hepatitis B virus e antigen-positive chronic hepatitis B.

Jiang et al. 2010The Journal of international medical researchcited by 13

PMID 21227010DOI 10.1177/147323001003800620PUB-21227010

Full text at the publisher5 results

Publisher page See results (5)

Indexing hint: Randomized controlled trial · 2006

9 results

Efficacy of thymosin alpha-1 and interferon alpha in treatment of chronic viral hepatitis B: a randomized controlled study.

You et al. 2006World journal of gastroenterologycited by 32

PMID 17075991PMC4125683DOI 10.3748/wjg.v12.i41.6715PUB-17075991

Rights unknown9 results

Source link See results (9)

Indexing hint: Randomized controlled trial · 2005

7 results

The efficacy and safety of thymosin alpha-1 in Japanese patients with chronic hepatitis B; results from a randomized clinical trial.

Iino et al. 2005Journal of viral hepatitiscited by 40

PMID 15850471DOI 10.1111/j.1365-2893.2005.00633.xPUB-15850471

Full text at the publisher7 results

Publisher page See results (7)

Indexing hint: Randomized controlled trial · 1996

5 results

A randomized controlled trial of thymosin-alpha1 versus interferon alfa treatment in patients with hepatitis B e antigen antibody--and hepatitis B virus DNA--positive chronic hepatitis B.

Andreone et al. 1996Hepatology (Baltimore, Md.)cited by 56

PMID 8855175DOI 10.1002/hep.510240404PUB-08855175

Rights unknown5 results

Source link See results (5)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedUsman Z, Mijocevic H, Karimzadeh H, Daumer M, Al-Mathab M, Bazinet M, Frishman D, Vaillant A, Roggendorf M. Kinetics of hepatitis B surface antigen quasispecies during REP 2139-Ca therapy in HBeAg-positive chronic HBV infection. J Viral Hepat. 2019 Dec;26(12):1454-1464. doi: 10.1111/jvh.13180. Epub 2019 Aug 13. PMID 31323705

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 55 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * HBsAg+ * Anti-HBs negative * HBV titer \> 1x10\^7 copies / ml * Treatment naïve * HIV / HCV / 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 * Evidence of liver cirrhosis * A history of ascites, hepatic encephalopathy or variceal hemorrhage * Body weight \> 100 kg * Platelet count \< 75,000, polymorphonuclear cell count \< 1,500 or hematocrit \< 33% * Alpha feto protein \> 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

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