Clinical Trial Results:
A PHASE 2, EXPLORATORY STUDY EVALUATING THE SAFETY AND ANTIVIRAL EFFICACY OF INARIGIVIR SOPROXIL IN NON-CIRRHOTIC, HEPATITIS B e ANTIGEN NEGATIVE SUBJECTS INFECTED WITH CHRONIC HEPATITIS B VIRUS AND RECEIVING OR STOPPING TREATMENT WITH A NUCLEOSIDE/NUCLEOTIDE INHIBITOR
|
Summary
|
|
EudraCT number |
2019-000896-17 |
Trial protocol |
GB |
Global end of trial date |
16 Jul 2020
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
08 Nov 2020
|
First version publication date |
08 Nov 2020
|
Other versions |
|
Summary report(s) |
Adverse event listing |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
|
Trial identification
|
|||
Sponsor protocol code |
SBP-9200-HBV-206
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
|
Sponsors
|
|||
Sponsor organisation name |
Spring Bank Pharmaceuticals, Inc.
|
||
Sponsor organisation address |
35 Parkwood Drive, Suite 210, Hopkinton, United States, MA 01748
|
||
Public contact |
Don Mitchell, Spring Bank Pharmaceuticals, Inc., 1 508 689 9737, dmitchell@springbankpharm.com
|
||
Scientific contact |
Don Mitchell, Spring Bank Pharmaceuticals, Inc., 1 508 689 9737, dmitchell@springbankpharm.com
|
||
|
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
|
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
16 Sep 2020
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
16 Jul 2020
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
16 Jul 2020
|
||
Was the trial ended prematurely? |
No
|
||
|
General information about the trial
|
|||
Main objective of the trial |
The primary objective of the original protocol was to identify safety and antiviral efficacy of inarigivir in participants receiving nucleoside/nucleotide (NUC) analogue inhibitors and in subjects who discontinue NUCs.
The primary objective was amended in Standalone Protocol Amendment 1.1. dated 05 Mar 2020 to ensure adequate safety follow-up of subjects who received treatment under Protocol SBP-9200-HBV-206.
|
||
Protection of trial subjects |
The Investigator explained the benefits and risks of participation in the study to each subject or the subject's legally acceptable representative and obtained written informed consent prior to the subject entering the study and before initiation of any study-related procedure.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
18 Jun 2019
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
Yes
|
||
|
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
United Kingdom: 25
|
||
Country: Number of subjects enrolled |
Canada: 39
|
||
Worldwide total number of subjects |
64
|
||
EEA total number of subjects |
25
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
58
|
||
From 65 to 84 years |
6
|
||
85 years and over |
0
|
||
|
|||||||||||||||
|
Recruitment
|
|||||||||||||||
Recruitment details |
- | ||||||||||||||
|
Pre-assignment
|
|||||||||||||||
Screening details |
Screening was performed up to 28 days before Visit 2 to determine the eligibility of each subject. | ||||||||||||||
|
Period 1
|
|||||||||||||||
Period 1 title |
Overall study (overall period)
|
||||||||||||||
Is this the baseline period? |
Yes | ||||||||||||||
Allocation method |
Randomised - controlled
|
||||||||||||||
Blinding used |
Not blinded | ||||||||||||||
|
Arms
|
|||||||||||||||
|
Arm title
|
Inarigivir | ||||||||||||||
Arm description |
- | ||||||||||||||
Arm type |
Experimental | ||||||||||||||
Investigational medicinal product name |
Inarigivir soproxil
|
||||||||||||||
Investigational medicinal product code |
|||||||||||||||
Other name |
|||||||||||||||
Pharmaceutical forms |
Tablet
|
||||||||||||||
Routes of administration |
Oral use
|
||||||||||||||
Dosage and administration details |
The initial dose of inarigivir administered was 400 mg daily with or without a Nucleoside/Nucleotide Inhibitor (NUC). Doses were administered as 2 inarigivir 200-mg tablets at least 1 hour before or after meals.
|
||||||||||||||
|
|||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Baseline characteristics reporting groups
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Overall study
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
Inarigivir
|
||
Reporting group description |
- | ||
|
|||||||
End point title |
Treatment emergent adverse events (TEAEs) [1] | ||||||
End point description |
|||||||
End point type |
Primary
|
||||||
End point timeframe |
From first dose to end of study
|
||||||
| 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 analyses were performed on this endpoint, as per protocol |
|||||||
|
|||||||
| No statistical analyses for this end point | |||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information [1]
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
From first dose to end of study.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
22.1
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Inarigivir
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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: Only SAEs have been coded and reported within the EudraCT results database. A full listing of all adverse events (non-coded) is appended to the results dataset. |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||
Substantial protocol amendments (globally) |
|||||||
| Were there any global substantial amendments to the protocol? Yes | |||||||
Date |
Amendment |
||||||
05 Mar 2020 |
Protocol standalone amendment 1.1 was implemented following the Urgent Safety Measure halt and implemented the following protocol changes:
* Planned follow up period of 24 weeks including the following:
- All patients to have weekly monitoring of liver function tests until results were normal or equal to baseline results for 4 consecutive weeks. Upon those 4 normal results, they were to return to the original schedule for the remainder of the 24 week follow up period.
- If a patient was symptomatic or had elevated liver function tests, they were to have 2x weekly monitoring of liver function tests until there were normal results for 4 consecutive weeks. Upon those 4 normal results, they were to return to the original schedule for the remainder of the 24 week follow up period.
- Patients with nausea, vomiting, abdominal pain or other symptoms of hepatic dysfunction who showed abnormal ALT/AST and an increase in INR or Bilirubin were to be considered for hospitalisation for biopsy and monitoring. All AEs or SAEs were to be followed until resolution.
- Patients who had not returned to normal results at the 24 week follow up timepoint were to be followed for an additional 24 weeks.
* Women of childbearing potential were to agree to use a highly effective method of contraception for 3 months after discontinuing study treatment, and men with female partners who were of childbearing potential were to agree that they or their partners would use a highly effective method of contraception for 3 months after discontinuing study treatment. |
||||||
Interruptions (globally) |
|||||||
| Were there any global interruptions to the trial? Yes | |||||||
|
|||||||
Limitations and caveats |
|||||||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||||||
| None reported | |||||||
