Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
Trial record 84 of 359 for:    hepatitis b | Open Studies

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2017 by Alios Biopharma Inc.
Sponsor:
Information provided by (Responsible Party):
Alios Biopharma Inc.
ClinicalTrials.gov Identifier:
NCT03125213
First received: April 12, 2017
Last updated: April 19, 2017
Last verified: April 2017
  Purpose

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)

Condition Intervention Phase
Hepatitis B, Chronic
Drug: AL-3778
Drug: Peginterferon Alfa-2A
Drug: Placebo Oral Tablet
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Phase 2a, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety, Efficacy, and Pharmacokinetics of AL-3778 in Combination With Peginterferon Alpha-2a in Treatment Naïve Chronic Hepatitis B Subjects Who Are HBeAg-positive

Resource links provided by NLM:


Further study details as provided by Alios Biopharma Inc.:

Primary Outcome Measures:
  • Mean change (measured in log10 IU/mL) in serum HBsAg from baseline at Week 24. [ Time Frame: Day 1 to Week 24 ]

Secondary Outcome Measures:
  • Incidence and severity of AEs [ Time Frame: Screening to Week 72 ]
  • Incidence and severity of laboratory abnormalities [ Time Frame: Screening to Week 72 ]
  • Incidence of serious adverse events (SAEs). [ Time Frame: Screening to Week 72 ]
  • Incidence and severity of AEs leading to study drug discontinuation. [ Time Frame: Screening to Week 72 ]
  • Changes in serum HBV DNA over time [ Time Frame: Day 1 to Week 72 ]
  • Proportion of subjects with ALT normalization [ Time Frame: Day 1 to Week 72 ]
  • Incidence and severity of hepatic flares on treatment [ Time Frame: Day 1 to Week 48 ]
  • Incidence and severity of hepatic flares off-treatment. [ Time Frame: Week 48 to week 72 ]
  • Proportions of subjects with HBeAg loss and/or seroconversion. [ Time Frame: Day 1 to Week 72 ]
  • Proportions of subjects with HBsAg loss and/or seroconversion. [ Time Frame: Day 1 to Week 72 ]
  • Changes in serum HBsAg and serum HBeAg levels over time. [ Time Frame: Day 1 to Week 72 ]
  • Proportion of subjects experiencing a viral breakthrough on treatment. [ Time Frame: Day 1 to Week 48 ]
  • Assess emergence of treatment-associated mutations during study treatment and follow-up with a focus on subjects with treatment failure [ Time Frame: Day 1 to Week 72 ]
  • Individually derived Bayesian estimates of AL-3778 Steady state plasma concentration (C0h) [ Time Frame: Week 2 ]
  • Individually derived Bayesian estimates of AL-3778 area under the plasma concentration curve vs time (AUC0-12h) [ Time Frame: Week 2 ]
  • AL-3778 maximum observed plasma concentration (Cmax) [ Time Frame: Week 2 ]
  • AL-3778 Steady state plasma concentration (C0h) [ Time Frame: Week 2 ]
  • AL-3778 area under the plasma concentration curve vs time (AUC0-12h) [ Time Frame: Week 2 ]

Estimated Enrollment: 33
Anticipated Study Start Date: June 30, 2017
Estimated Study Completion Date: December 30, 2018
Estimated Primary Completion Date: December 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Peg-IFN plus AL-3778 Drug: AL-3778
AL-3778 tablets
Drug: Peginterferon Alfa-2A
Peginterferon Alfa-2A for subcutaneous injection
Placebo Comparator: Peg-IFN plus matching placebo Drug: Peginterferon Alfa-2A
Peginterferon Alfa-2A for subcutaneous injection
Drug: Placebo Oral Tablet
Placebo to Match AL-3778 tablet

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03125213

Contacts
Contact: Chris Westland 650-635-5500 cwestlan@ITS.JNJ.com

Locations
Mauritius
CAP Research Mauritius Not yet recruiting
Phoenix, Mauritius
Contact: Regine Rouzier         
Sponsors and Collaborators
Alios Biopharma Inc.
Investigators
Study Director: William Kennedy Alios Biopharma Inc.
  More Information

Responsible Party: Alios Biopharma Inc.
ClinicalTrials.gov Identifier: NCT03125213     History of Changes
Other Study ID Numbers: AL-3778-1003
Study First Received: April 12, 2017
Last Updated: April 19, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 26, 2017