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

NCT03125213 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: AL-3778-1003
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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)

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (1)

• Mean change (measured in log10 IU/mL) in serum HBsAg from baseline at Week 24.

  Day 1 to Week 24

Secondary Outcomes (18)

• Incidence and severity of AEs

  Screening to Week 72

• Incidence and severity of laboratory abnormalities

  Screening to Week 72

• Incidence of serious adverse events (SAEs).

  Screening to Week 72

• Incidence and severity of AEs leading to study drug discontinuation.

  Screening to Week 72

• Changes in serum HBV DNA over time

  Day 1 to Week 72

Study Arms (2)

Peg-IFN plus AL-3778

ACTIVE COMPARATOR

Drug: AL-3778; Drug: Peginterferon Alfa-2A

Peg-IFN plus matching placebo

PLACEBO COMPARATOR

Drug: Peginterferon Alfa-2A; Drug: Placebo Oral Tablet

Interventions

AL-3778 DRUG

AL-3778 tablets

Peg-IFN plus AL-3778

Peginterferon Alfa-2A DRUG

Peginterferon Alfa-2A for subcutaneous injection

Peg-IFN plus AL-3778; Peg-IFN plus matching placebo

Placebo Oral Tablet DRUG

Placebo to Match AL-3778 tablet

Peg-IFN plus matching placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A female subject must be of non-childbearing potential
• Subjects must have CHB infection, documented by serologic profile consistent for CHB infection at screening:
• serum HBsAg positive (for \>6 months)
• serum IgM anti-HBc negative
• Subjects are treatment-naïve and are serum HBeAg positive with:
• serum HBV DNA \>=20,000 IU /mL at screening
• HBsAg \>250 IU/mL at screening
• ≥2× upper limit of normal (ULN) ALT and ≤5× ULN at screening

You may not qualify if:

• Positive test for anti-HBs antibodies and anti-HBe antibodies.
• Subjects must have low levels of liver fibrosis that is classified as Metavir F0-F2
• Any history or current evidence of hepatic decompensation
• Subjects must have absence of hepatocellular carcinoma
• Subject with evidence of retinopathy on retinal fundus photographs
• Subjects with one or more of the following laboratory abnormalities at screening
• serum creatinine elevation \>1.0× ULN
• hemoglobin \<11 g/dL \[males\], \<10.5 g/dL \[females\]
• platelet count \<125× 109 cells/L
• absolute neutrophil count \<1.0× 109 cells/L
• total bilirubin \>1.0× ULN; unless known Gilbert's Disease or Dubin-Johnson Syndrome
• 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).

Sponsors & Collaborators

• Alios Biopharma Inc.: lead

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• William Kennedy

  Alios Biopharma Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2017
• First Posted: April 24, 2017
• Study Start: September 12, 2017
• Primary Completion: February 15, 2019
• Study Completion: February 15, 2019
• Last Updated: October 16, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share