NCT02791386

Brief Summary

The purpose of this study is to describe current rescue treatment pattern for nucleot(s)ide analogue (NA) resistance and assess the real-world treatment outcomes and health resources utilization of rescue treatments for drug resistance in a clinical cohort of Chinese patients with chronic hepatitis B (CHB).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
383

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

June 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

November 22, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2017

Completed
Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

11 months

First QC Date

June 1, 2016

Last Update Submit

November 9, 2017

Conditions

Hepatitis B

Outcome Measures

Primary Outcomes (2)

  • Direct medical costs associated with CHB patients who were regularly followed for drug resistance to NA therapy at the tertiary liver clinic of the Second Xiangya Hospital (SXH) in Changsha, Hunan, China

    Retrospectively collected from March 31, 2008 to August 15, 2016

  • Rescue treatments effect on direct medical costs associated with CHB patients who were followed for drug resistance to NA therapy at the tertiary liver clinic of SXH

    Retrospectively collected from March 31, 2008 to August 15, 2016

Secondary Outcomes (6)

  • Rescue treatment patterns associated with CHB patients who were regularly followed for their drug resistance to NA therapy at the tertiary liver clinic of SXH

    Retrospectively collected from March 31, 2008 to August 15, 2016

  • Virological response recurrence associated with rescue treatments for drug resistance to NA therapy in CHB patients who were followed at the tertiary liver clinic of SXH

    Retrospectively collected from March 31, 2008 to August 15, 2016

  • Biochemical response recurrence associated with rescue treatments for drug resistance to NA therapy in CHB patients who were followed at the tertiary liver clinic of SXH

    Retrospectively collected from March 31, 2008 to August 15, 2016

  • Drug resistance recurrence associated with rescue treatments for drug resistance to NA therapy in CHB patients who were followed at the tertiary liver clinic of SXH

    Retrospectively collected from March 31, 2008 to August 15, 2016

  • Rescue treatments effect on liver-related complications in CHB patients who were followed up for drug resistance to NA therapy at the tertiary liver clinic of SXH

    Retrospectively collected from March 31, 2008 to August 15, 2016

  • +1 more secondary outcomes

Study Arms (1)

Chinese Patients With CHB and Drug Resistance to NA Therapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary Care Clinic

You may qualify if:

  • CHB patient with drug resistance confirmed by hepatitis B virus (HBV) gene mutation and virological breakthrough
  • Patient receiving rescue treatments for drug resistance to previous NA therapy for CHB
  • Patient who was regularly followed at least every 6 months for drug resistance at the tertiary liver clinic of SXH

You may not qualify if:

  • Patient with a diagnosis of hepatocellular carcinoma, decompensated cirrhosis, and/or liver transplantation prior to the development of drug resistance to NA therapy for CHB
  • Patient with co-infection with hepatitis C virus, hepatitis D virus, and/or human immunodeficiency virus
  • Patient with life expectancy less than 6 months after the date of the first laboratory test indicating drug resistance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Changsha, Hunan, 410011, China

Location

Related Links

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2016

First Posted

June 6, 2016

Study Start

November 22, 2016

Primary Completion

October 30, 2017

Study Completion

October 30, 2017

Last Updated

November 14, 2017

Record last verified: 2017-11

Locations

CN(1)