Clinical Trial Results:
A Long Term Follow-up Registry of Subjects Treated in A Gilead-Sponsored Trial in Subjects with Chronic Hepatitis B Infection
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Summary
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EudraCT number |
2015-001050-16 |
Trial protocol |
IT |
Global end of trial date |
14 Aug 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
29 Aug 2018
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First version publication date |
29 Aug 2018
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
GS-US-330-1508
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02258581 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Gilead Sciences
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Sponsor organisation address |
333 Lakeside Drive , Foster City, CA, United States, 94404
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Public contact |
Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
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Scientific contact |
Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
14 Aug 2017
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
14 Aug 2017
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
The primary objective of this study was to evaluate the long term effects of hepatitis B virus (HBV) treatment of the parental study on the HBV serologic changes through Week 144.
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Protection of trial subjects |
The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements.
This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
09 Dec 2014
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United States: 147
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Country: Number of subjects enrolled |
Canada: 21
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Country: Number of subjects enrolled |
Korea, Democratic People's Republic of: 18
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Country: Number of subjects enrolled |
New Zealand: 11
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Country: Number of subjects enrolled |
Hong Kong: 5
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Country: Number of subjects enrolled |
India: 5
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Country: Number of subjects enrolled |
Australia: 1
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Country: Number of subjects enrolled |
Netherlands: 6
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Country: Number of subjects enrolled |
Italy: 26
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Worldwide total number of subjects |
240
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EEA total number of subjects |
32
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
230
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From 65 to 84 years |
10
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85 years and over |
0
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Recruitment
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Recruitment details |
Participants were enrolled at study sites in North America, Europe, and Asia-Pacific. The first participant was screened on 09 December 2014. The last study visit occurred on 14 August 2017. | ||||||||||||||
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Pre-assignment
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Screening details |
245 participants were screened. | ||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||
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Arms
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Arm title
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Registry Study | ||||||||||||||
Arm description |
Participants who had been treated in selected Gilead-sponsored studies (GS-US-330-0101, GS-US-330-1401, GS-US-283-1059, and GS-US-174-0149) for chronic hepatitis B. | ||||||||||||||
Arm type |
No Intervention | ||||||||||||||
Investigational medicinal product name |
HBV treatment in the parental study
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
No investigational treatment was administered in this study. Routes of administration and pharmaceutical forms are entered because these are required data elements in the system.
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Baseline characteristics reporting groups
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Reporting group title |
Registry Study
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Reporting group description |
Participants who had been treated in selected Gilead-sponsored studies (GS-US-330-0101, GS-US-330-1401, GS-US-283-1059, and GS-US-174-0149) for chronic hepatitis B. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Registry Study
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Reporting group description |
Participants who had been treated in selected Gilead-sponsored studies (GS-US-330-0101, GS-US-330-1401, GS-US-283-1059, and GS-US-174-0149) for chronic hepatitis B. | ||
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End point title |
Percentage of participants with serum hepatitis B surface antigen (HBsAg) decline ≥ 0.5 log10 IU/ml from baseline at Week 48 [1] | ||||||||
End point description |
Participants in the Full Analysis Set (who were HBsAg positive at baseline) with available data were analyzed.
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End point type |
Primary
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End point timeframe |
Week 48
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical comparison was planned or performed. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of participants who remain HBsAg negative at Week 48 [2] | ||||||||
End point description |
Participants in the Full Analysis Set (who were HBsAg negative at baseline) with available data were analyzed.
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End point type |
Primary
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End point timeframe |
Week 48
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical comparison was planned or performed. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of participants with serum HBsAg decline ≥ 0.5 log10 IU/ml from baseline at Week 144 | ||||||||
End point description |
Participants in the Full Analysis Set (who were HBsAg positive at baseline) with available data were analyzed.
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End point type |
Secondary
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End point timeframe |
Week 144
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of participants who achieve HBsAg loss at Week 48 | ||||||||
End point description |
Participants in the Full Analysis Set (who were HBsAg positive at baseline) with available data were analyzed.
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End point type |
Secondary
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End point timeframe |
Week 48
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of participants who achieve HBsAg loss at Week 144 | ||||||||
End point description |
Participants in the Full Analysis Set (who were HBsAg positive at baseline) with available data were analyzed.
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End point type |
Secondary
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End point timeframe |
Week 144
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of participants with hepatitis B e antigen (HBeAg) loss and seroconversion at Week 48 | ||||||||
End point description |
Participants in the Full Analysis Set (who were HBeAg positive at baseline) with available data were analyzed.
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End point type |
Secondary
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End point timeframe |
Week 48
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of participants with HBeAg loss and seroconversion at Week 144 | ||||||||
End point description |
Participants in the Full Analysis Set (who were HBeAg positive at baseline) with available data were analyzed.
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End point type |
Secondary
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End point timeframe |
Week 144
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of participants who remain HBeAg negative and HBeAb positive at Week 48 | ||||||||
End point description |
Participants in the Full Analysis Set who achieved HBeAg seroconversion during the parental study were analyzed.
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End point type |
Secondary
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End point timeframe |
Week 48
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of participants with HBV DNA < the lower limit of quantitation (LLOQ < 20 IU/mL) at Week 48 | ||||||||
End point description |
Participants in the Full Analysis Set (who were on treatment with oral antiviral (OAV) for HBV) with available data were analyzed.
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End point type |
Secondary
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End point timeframe |
Week 48
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of participants with HBV DNA < LLOQ at Week 96 | ||||||||
End point description |
Participants in the Full Analysis Set (who were on treatment with OAV for HBV) with available data were analyzed.
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End point type |
Secondary
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End point timeframe |
Week 96
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of participants with HBV DNA < LLOQ at Week 144 | ||||||||
End point description |
Participants (who were on treatment with OAV for HBV) with available data were analyzed.
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End point type |
Secondary
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End point timeframe |
Week 144
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| No statistical analyses for this end point | |||||||||
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End point title |
Change from Baseline in HBV DNA at Week 48 | ||||||||
End point description |
Participants in the Full Analysis Set (all enrolled participants with at least one dose if one of the parental protocol defined treatment regimens and one visit during the registry) with available data were analyzed.
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End point type |
Secondary
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End point timeframe |
Week 48
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| No statistical analyses for this end point | |||||||||
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End point title |
Change from Baseline in HBV DNA at Week 96 | ||||||||
End point description |
Participants in the Full Analysis Set with available data were analyzed.
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End point type |
Secondary
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End point timeframe |
Week 96
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| No statistical analyses for this end point | |||||||||
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End point title |
Change from Baseline in HBV DNA at Week 144 | ||||||||
End point description |
Participants in the Full Analysis Set with available data were analyzed.
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End point type |
Secondary
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End point timeframe |
Week 144
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| No statistical analyses for this end point | |||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
Up to Week 144
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Adverse event reporting additional description |
Safety Analysis Set: participants with at least one dose of one of the parental protocol defined treatment regimens
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Assessment type |
Systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
None | ||
Dictionary version |
0
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| Frequency threshold for reporting non-serious adverse events: 5% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No participants experienced any adverse events during this registry. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||||||
Date |
Amendment |
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11 Mar 2015 |
1. Added language specifying study inclusion criteria for subjects who participated in Gilead-sponsored study number GS-US-174-0149
2. Revised study design and inclusion criteria so that Baseline visit may occur up to 120 days since the last study visit of Gilead-sponsored study for CHB
3. Updated analysis objectives and endpoints
4. Added language to specify distinction between symptom-directed physical exam and vital signs collection
5. Addition of quality of life assessments
6. Added language to clarify collection of adverse events deemed by investigator to be related to treatment from previous Gilead-sponsored CHB treatment protocol
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05 Oct 2016 |
1. Added language to clarify how Adverse Events, Serious Adverse Events, and Special Situations are collected and reported based on association with registry protocol mandated procedures, initial Gilead-sponsored study, or commercially approved Gilead product as part of CHB standard of care treatment
2. Removed references throughout to the observational nature of the study
3. Clarified that no formal sample size statistical analysis will be performed |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? Yes | |||||||
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Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||||||
| None reported | |||||||
