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Hepatitis B, ChronicPhase 2NCT02726789

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

A Phase 2 study testing REP 2139-Ca, pegylated interferon and entecavir in people with Hepatitis B, Chronic, run by Replicor Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Hepatitis B, Chronic
What is being tested?
REP 2139-Ca, pegylated interferon and entecavir
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
No sites listed yet
Study dates
Oct 2012to Dec 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 26Show fewer
  • 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 < 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

About this study

Official title: Therapeutic Safety and Efficacy of Combination Treatment With REP 2139-Ca and Pegasys in Patients With Chronic Hepatitis B

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.

Read the detailed description

Chronic hepatitis B is a long term condition caused by infection of the body with the hepatitis B virus (HBV). This infection often results in inflammation or scarring of the liver and can eventually lead to liver cirrhosis and liver failure. These infections are also one of the major causes of the development of hepatocellular carcinoma (liver cancer).

Although some drugs have been approved to treat chronic hepatitis B infections, they do not provide a complete cure except in rare cases (a cure generally means that a person loses the hepatitis B virus from the blood and the liver and develops a durable immunological control of subsequent HBV infection). However, these drugs do significantly decrease the risk of liver damage and liver cancer arising from the presence of a chronic liver infection by slowing or stopping the production of infectious virus. Thus the primary problem associated with currently available drugs is the lack of clearance of the virus from the hepatocytes which necessitates long term treatment with these drugs. There is clearly a need to identify new drugs that can benefit patients with chronic hepatitis B infections. Nucleic acid-based polymers (NAPs) are a new class of broad-spectrum antiviral compounds which act against HBV infection by blocking the release of the surface antigen protein (HBsAg) from infected hepatocytes.

Current interim data analysis from the REP 102 assessing the activity of the NAP REP 9AC' (REP 2139, given as a calcium chelate complex [REP 2139-Ca]) in patients with chronic HBV infection indicates the following:

  1. REP 2139-Ca is generally well tolerated and patients tolerate short term combined treatment (13-26 weeks) of pegylated interferon and / or thymosin alpha
  2. REP 2139-Ca has achieved serum HBsAg reduction or clearance 9 of 9 patients receiving combined therapy.
  3. Appearance of substantial titers of serum anti-HBs occur with the addition of immunotherapy.
  4. After all treatment is withdrawn, 8 / 9 patients achieved HBV DNA < 116 copies / ml (LLOQ of the Roche Cobas platform) and sustained suppression of viremia (HBV DNA < 1000 cpm, HBsAg < 1 IU / ml) for a period of greater than 1 year was observed in four patients.

This exploratory study is designed to examine if REP 2139-Ca can be safely combined with a full course of pegylated interferon in treatment naive patients and in patients with previous and continuing therapy with entecavir and that similar antiviral effects can be observed as in the previous REP 101 and 102 protocols.

Being tested
REP 2139-Ca, pegylated interferon, entecavir
Keywords
nucleic acid polymer REP 2139 HBsAg hepatitis B
Medical subject headings
Hepatitis B, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • REP 2139-CaDrug

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

  • pegylated interferonDrug

    Also called pegylated interferon alpha 2a, Pegasys(R)

    immunotherapy

  • entecavirDrug

    Also called local generic entecavir

    local generic entecavir

Study groups in NCT02726789
Study groupRoleWhat they receive
ExperimentalExperimentalPatients either treatment naive or with HBV DNA controlled with entecavir receive REP 2139-Ca in combination with pegylated interferon. Only patients receiving entecavir at enrollment continue to receive entecavir during treatment in the study.
Receives: Drug: REP 2139-Ca; Drug: pegylated interferon; Drug: entecavir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients Experiencing Treatment Emergent Laboratory Test Abnormalities or Adverse Events.

    To record side effects, symptoms and adverse effects of exposure to REP 2139-Ca when combined pegylated interferon.

    Measured: 48 weeks (treatment)

Secondary outcomes (3)

  1. Number of Patients Experiencing Reductions in Serum HBsAg

    To assess antiviral activity of REP 2139-Ca when combined with pegylated interferon on serum HBsAg.

    Measured: 48 weeks (treatment)

  2. Number of Patients Experiencing Reductions in Serum HBV DNA

    To assess antiviral activity of REP 2139-Ca when combined with pegylated interferon on serum HBV DNA.

    Measured: 48 weeks (treatment)

  3. Number of Patients Experiencing Serum Anti-HBs > 10 mIU / ml

    To assess antiviral activity of REP 2139-Ca when combined with pegylated interferon on anti-HBsAg antibody titer.

    Measured: 48 weeks (treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2016 (estimated)
  2. Study startOct 2012
  3. Primary completionSep 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02726789
Sponsor's protocol ID
REP 201
Status last verified
Feb 2017
First submitted
18 Mar 2016
Last updated
8 May 2019
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Noordeen F, Vaillant A, Jilbert AR. Nucleic acid polymers inhibit duck hepatitis B virus infection in vitro. Antimicrob Agents Chemother. 2013 Nov;57(11):5291-8. doi: 10.1128/AAC.01003-13. Epub 2013 Aug 12.

    PubMed 23939902

  • Noordeen F, Vaillant A, Jilbert AR. Nucleic acid polymers prevent the establishment of duck hepatitis B virus infection in vivo. Antimicrob Agents Chemother. 2013 Nov;57(11):5299-306. doi: 10.1128/AAC.01005-13. Epub 2013 Aug 12.

    PubMed 23939904

  • Noordeen F, Scougall CA, Grosse A, Qiao Q, Ajilian BB, Reaiche-Miller G, Finnie J, Werner M, Broering R, Schlaak JF, Vaillant A, Jilbert AR. Therapeutic Antiviral Effect of the Nucleic Acid Polymer REP 2055 against Persistent Duck Hepatitis B Virus Infection. PLoS One. 2015 Nov 11;10(11):e0140909. doi: 10.1371/journal.pone.0140909. eCollection 2015.

    PubMed 26560490

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing REP 2139-Ca, pegylated interferon and entecavir in people with Hepatitis B, Chronic, run by Replicor Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients Experiencing Treatment Emergent Laboratory Test Abnormalities or Adverse Events. (time frame: 48 weeks (treatment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02726789, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2019.

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