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A Study Evaluating AL-3778 in Combination With Peginterferon Alpha-2a in Chronic Hepatitis B Subjects

NCT ID: NCT03125213

Last Updated: 2017-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-12

Study Completion Date

2019-02-15

Brief Summary

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This is a Phase 2a, multi-center, randomized, double-blind, placebo-controlled study evaluating the safety, efficacy, and pharmacokinetics (PK) of AL-3778 in combination with Peg-IFN in subjects with Hepatitis B e antigen (HBeAg) positive CHB virus infection who are treatment-naïve.

The study will consist of a screening phase , a double-blind treatment phase followed by treatment with Peg-IFN alone, and a post-treatment follow-up phase.

Approximately 30 subjects to complete the study. Eligible subjects will be randomized into 2 treatment arms in a 2:1 ratio (active:placebo) to receive one of the following treatments:

* Arm A: Peg-IFN plus AL-3778 (N=20)
* Arm B: Peg-IFN plus matching placebo (N=10)

Detailed Description

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Conditions

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Hepatitis B, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Peg-IFN plus AL-3778

Group Type ACTIVE_COMPARATOR

AL-3778

Intervention Type DRUG

AL-3778 tablets

Peginterferon Alfa-2A

Intervention Type DRUG

Peginterferon Alfa-2A for subcutaneous injection

Peg-IFN plus matching placebo

Group Type PLACEBO_COMPARATOR

Peginterferon Alfa-2A

Intervention Type DRUG

Peginterferon Alfa-2A for subcutaneous injection

Placebo Oral Tablet

Intervention Type DRUG

Placebo to Match AL-3778 tablet

Interventions

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AL-3778

AL-3778 tablets

Intervention Type DRUG

Peginterferon Alfa-2A

Peginterferon Alfa-2A for subcutaneous injection

Intervention Type DRUG

Placebo Oral Tablet

Placebo to Match AL-3778 tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. A female subject must be of non-childbearing potential
2. Subjects must have CHB infection, documented by serologic profile consistent for CHB infection at screening:

1. serum HBsAg positive (for \>6 months)
2. serum IgM anti-HBc negative
3. Subjects are treatment-naïve and are serum HBeAg positive with:

1. serum HBV DNA \>=20,000 IU /mL at screening
2. HBsAg \>250 IU/mL at screening
3. ≥2× upper limit of normal (ULN) ALT and ≤5× ULN at screening

Exclusion Criteria

1. Positive test for hepatitis A virus immunoglobulin, hepatitis delta antibody (Ab), hepatitis C Ab, human immunodeficiency virus (HIV) Ab and/or evidence of clinically relevant active infection that would interfere with study conduct or its interpretation would also lead to exclusion.
2. Positive test for anti-HBs antibodies and anti-HBe antibodies.
3. Subjects must have low levels of liver fibrosis that is classified as Metavir F0-F2
4. Any history or current evidence of hepatic decompensation
5. Subjects must have absence of hepatocellular carcinoma
6. Subject with evidence of retinopathy on retinal fundus photographs
7. Exclusions related to interferon use for the purposes of this study
8. Subjects with one or more of the following laboratory abnormalities at screening

1. serum creatinine elevation \>1.0× ULN
2. hemoglobin \<11 g/dL \[males\], \<10.5 g/dL \[females\]
3. platelet count \<125× 109 cells/L
4. absolute neutrophil count \<1.0× 109 cells/L
5. total bilirubin \>1.0× ULN; unless known Gilbert's Disease or Dubin-Johnson Syndrome
9. Subjects having received an investigational agent or investigational vaccine, or having received a biological product within 12 weeks or 5 half-lives (whichever is longer) prior to baseline (first intake of study drugs).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alios Biopharma Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William Kennedy

Role: STUDY_DIRECTOR

Alios Biopharma Inc.

Countries

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Mauritius

Other Identifiers

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AL-3778-1003

Identifier Type: -

Identifier Source: org_study_id