NCT01475851

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of once-daily treatment with GSK548470 300 mg in Japanese patients with compensated chronic hepatitis B with poor response to other drugs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2011

Typical duration for phase_3

Geographic Reach
1 country

11 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

First Submitted

Initial submission to the registry

November 17, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2011

Completed
10 days until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
5 months until next milestone

Results Posted

Study results publicly available

November 4, 2013

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

June 22, 2015

Status Verified

May 1, 2015

Enrollment Period

1.5 years

First QC Date

November 17, 2011

Results QC Date

August 22, 2013

Last Update Submit

June 18, 2015

Conditions

Hepatitis B, Chronic

Keywords

Tenofovir disoproxil fumarate, compensated chronic hepatitis B

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With HBV DNA Level < 2.1 log10 Copies/mL at Week 24

    The number of participants with serum hepatitis B virus deoxyribonucleic acid (HBV DNA) level \< the lower limit of quantitation (2.1 log10 copies/millilitres\[copies/mL\]) (i.e., the rate of suppression) at Week 24 was summarized. Statistical analysis was not provided for the number of participants achieving HBV DNA \<2.1 log10 copies/mL (at Week 24). Missing values observed during the treatment period was imputed by the last observation carried forward (LOCF) method.

    Week 24

Secondary Outcomes (10)

  • Mean Change From Baseline in Serum HBV DNA Level at Week 24, Week 48 and Week 96

    Baseline and Week 24, Week 48 and Week 96

  • Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 48 and Week 96

    Week 48 and Week 96

  • Number of Participants With Alanine Aminotransferase (ALT) Normalization at Week 24, Week 48 and Week 96

    Week 24, Week 48 and Week 96

  • Number of Participants With HBeAg Loss at Week 24, Week 48 and Week 96

    Week 24, Week 48 and Week 96

  • Number of Participants With HBeAg/HBeAb Seroconversion at Week 24, Week 48 and Week 96

    Week 24, Week 48 and Week 96

  • +5 more secondary outcomes

Study Arms (1)

GSK548470 300 mg

EXPERIMENTAL

GSK548470 300 mg tablet is administered orally once daily

Drug: GSK548470 300 mg tablet

Interventions

GSK548470 300 mg tabletDRUG

Blue tablets containing 300 mg of tenofovir disoproxil fumarate

Also known as: GSK548470
GSK548470 300 mg

Eligibility Criteria

Age16 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The ability to understand and sign a written informed consent form
  • to 69 years of age at the time of informed consent
  • Females of childbearing potential must have a negative pregnancy test and agree to avoidance of pregnancy
  • Subject must show QTc \<450 millisecond (msec) or \<480msec with Bundle Branch Block
  • Chronic HBV infection, defined as positive serum HBsAg for at least 6 month
  • Subjects currently treated with LAM/ADV, ETV or ETV/ADV for greater than 24 weeks
  • Chronic hepatitis B ; HBV NDA \>= 4 log10 copies/mL, Chronic hepatitis B with cirrhosis ; HBV NDA \>= 3 log10 copies/mL
  • Serum ALT \<= 10 × ULN
  • Creatinine clearance \>= 70 mL/min
  • Haemoglobin \>= 8 g/dL
  • WBC \>= 1,000 /mm3

You may not qualify if:

  • Decompensated liver disease
  • Co-infection with HIV or HCV
  • Autoimmune hepatitis rather than chronic hepatitis B
  • Subject with serious complication
  • Received or have a plan for solid organ or bone marrow transplantation
  • Has proximal tubulopathy
  • History of hypersensitivity to nucleoside and/or nucleotide analogues
  • Evidence of hepatocellular carcinoma by diagnostic imaging at screening and/or serum α-fetoprotein \> 50 ng/mL at screening
  • History of HCC
  • Received any interferon or HB vaccine therapy within 24 weeks prior to initiation
  • Received overdose NSAIDs, excluding temporary or topical use, within 7 days prior to initiation
  • Received drugs for injection containing glycyrrhizin as the main component within 4 weeks prior to initiation
  • Received drugs causing renal impairment, competitors of renal excretion, immunosuppressants, chemotherapeutics and/or corticosteroids within 8 weeks prior to initiation
  • Participation in another clinical study within 6 months of study entry or planned participation in another clinical study after entry to this study
  • Woman who is pregnant, lactating, possibly pregnant or planning a pregnancy during the study period
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

GSK Investigational Site

Aichi, 466-8560, Japan

Location

GSK Investigational Site

Aichi, 467-8602, Japan

Location

GSK Investigational Site

Chiba, 260-8677, Japan

Location

GSK Investigational Site

Fukuoka, 803-8505, Japan

Location

GSK Investigational Site

Hiroshima, 734-8551, Japan

Location

GSK Investigational Site

Hokkaido, 060-0033, Japan

Location

GSK Investigational Site

Kagoshima, 890-8520, Japan

Location

GSK Investigational Site

Kanagawa, 213-8587, Japan

Location

GSK Investigational Site

Miyagi, 980-8574, Japan

Location

GSK Investigational Site

Tokyo, 105-8470, Japan

Location

GSK Investigational Site

Tokyo, 180-8610, Japan

Location

Related Publications (1)

  • Kumada H, Koike K, Suyama K, Ito H, Itoh H, Sugiura W. Efficacy and safety of tenofovir disoproxil fumarate rescue therapy for chronic hepatitis B patients who failed other nucleos(t)ide analogs. Hepatol Res. 2017 Sep;47(10):1032-1041. doi: 10.1111/hepr.12842. Epub 2016 Dec 21.

    PMID: 27862721DERIVED

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Tablets

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

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2011

First Posted

November 21, 2011

Study Start

December 1, 2011

Primary Completion

June 1, 2013

Study Completion

October 1, 2014

Last Updated

June 22, 2015

Results First Posted

November 4, 2013

Record last verified: 2015-05

Locations

JP(11)