NCT02366208

Brief Summary

This trial is to assess the efficacy and safety of Polyethylene Glycol thymosin alpha1 (PEG-Tα1), a new long immunomodulator (Category 1.1 of Chemical Drugs) being developed from Hansoh Pharmaceutical of China, in combination with adefovir in HBeAg-positive patients with chronic hepatitis B.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2011

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2015

Completed
Last Updated

February 19, 2015

Status Verified

January 1, 2015

Enrollment Period

2.1 years

First QC Date

February 12, 2015

Last Update Submit

February 12, 2015

Conditions

Hepatitis B, Chronic

Keywords

Polyethylene Glycol Thymosin alpha1AdefovirHepatitis B e Antigens positive

Outcome Measures

Primary Outcomes (1)

  • loss of HBeAg

    48 weeks

Secondary Outcomes (3)

  • loss of HBV DNA

    week 4, 12, 24, 36 and 48

  • HBeAg seroconversion

    week 4, 12, 24, 36 and 48

  • alanine aminotransferase normalization

    week 4, 12, 24, 36 and 48

Study Arms (2)

PEG-Tα1

EXPERIMENTAL

PEG-Tα1 (1.6 mg/ml, once a week, taken subcutaneously) for 24 weeks and adefovir (10 mg, once daily, taken orally) for 48 weeks

Drug: PEG-Tα1Drug: Adefovir

Placebo to match PEG-Tα1

PLACEBO COMPARATOR

PEG-Tα1 placebo (1ml, once a week, taken subcutaneously) for 24 weeks and adefovir (10 mg, once daily, taken orally) for 48 weeks

Drug: Placebo to match PEG-Tα1Drug: Adefovir

Interventions

PEG-Tα1DRUG

1.6 mg/ml, once a week, taken subcutaneously

Also known as: Polyethylene Glycol Thymosin alpha1
PEG-Tα1
Placebo to match PEG-Tα1DRUG

1ml, once a week, taken subcutaneously

Placebo to match PEG-Tα1
AdefovirDRUG

10 mg, once daily, taken orally for 48 weeks

PEG-Tα1Placebo to match PEG-Tα1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic hepatitis B for more than 6 months
  • ALT \> 2 × Upper Limit Normal (ULN)
  • Serum bilirubin \< 2 × ULN.
  • Positive HBeAg and HBV-DNA between 1.00E＋05 IU/ml and 9.99E＋09 IU/ml.
  • Informed Consent Form (ICF) signed.

You may not qualify if:

  • Hepatitis A,C,D,E or HIV infection.
  • Autoimmune hepatitis.
  • Hepatic cirrhosis.
  • Serum creatinine \> 1.5 × ULN or Ccr \< 50 ml/min, Haemoglobin \< 110g/L (male) or \< 100g/L (female), Platelet\< 80 E＋09/L, Serum albumin ≤ 32g/L, or Serum albumin/globulin (A/G) ≤0.9, Neutrophile granulocyte \< 1.0 E＋09/L, Prothrombin time\>ULN＋3 seconds, Cholinesterase\<2500U/L.
  • Hepatitic carcinoma or Alpha Fetal Protein (AFP) \> 100ng/ml
  • Patients with other severe diseases combined, which could affect the therapy.
  • Patients accepted other clinical trial within 6 months before the first administrated.
  • Patients accepted immunomodulating or anti-viral treatment within 6 months before the trial.
  • Patients with autoimmune disease.
  • Thymosin allergy.
  • Pregnant or breast feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

302 Military Hoapital of China

Beijing, Beijing Municipality, China

Location

Hainan General Hospital

Haikou, Hainan, China

Location

The Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

81 Military Hospital of China

Nanjing, Jiangsu, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Location

The Second Hospital of Nanjing

Nanjing, Jiangsu, China

Location

The First Hospital of Jilin University

Changchun, Jilin, China

Location

The Sixth People's Hospital of Shenyang

Shenyang, Liaoning, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

Location

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

Location

West China Hospital Sichuan University

Chengdu, Sichuan, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

adefovir

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

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

February 12, 2015

First Posted

February 19, 2015

Study Start

May 1, 2011

Primary Completion

June 1, 2013

Study Completion

August 1, 2013

Last Updated

February 19, 2015

Record last verified: 2015-01

Locations

CN(12)