Immunogenicity of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients

Sponsor
Shanxi Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT02991599
Collaborator
Centers for Disease Control and Prevention, China (Other)
196
2
43

Study Details

Study Description

Brief Summary

This is a randomized, controlled trial. The study will evaluate the immunogenicity, immune persistence, and safety of 20 µg and 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 in methadone maintenance treatment patients.

Condition or Disease Intervention/Treatment Phase
  • Biological: 60 µg dose hepatitis B vaccine
  • Biological: 20 µg dose hepatitis B vaccine
Phase 4

Detailed Description

Comparison of 2 vaccination strategy against Hepatitis B in patients with Methadone Maintenance Treatment

Intervention:

Arm 1 : 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6;

Arm 2 : 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6.

Study Design

Study Type:
Interventional
Actual Enrollment :
196 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Immunogenicity and Persistence of Intramuscular High Dose Recombinant Hepatitis B Vaccine in Methadone Maintenance Treatment Patients in China: a Randomized Controlled Trial
Study Start Date :
Oct 1, 2014
Actual Primary Completion Date :
Jul 1, 2015
Actual Study Completion Date :
May 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: 60 µg dose hepatitis B vaccine

60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6

Biological: 60 µg dose hepatitis B vaccine
three-dose, 60 µg per dose

Experimental: 20 µg dose hepatitis B vaccine

20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6

Biological: 20 µg dose hepatitis B vaccine
three-dose, 20 µg per dose

Outcome Measures

Primary Outcome Measures

  1. Number and Rate of Participants With Anti-HBs Seroconversion at Month 7 [Month 7]

    The measurements of anti-HBs antibodies were determined quantitatively by CMIA( Chemiluminescent Microparticle Immunoassay ) . The accepted protective serum anti-HBs level was ≥10 mIU/ml.

Secondary Outcome Measures

  1. Anti-HBs Concentration at Month 7 [Month 7]

    The measurements of anti-HBs antibodies were determined quantitatively by CMIA( Chemiluminescent Microparticle Immunoassay )

  2. Anti-HBs Concentration at Month 12 [Month 12]

    The measurements of anti-HBs antibodies were determined quantitatively by CMIA( Chemiluminescent Microparticle Immunoassay )

  3. Number and Rate of Participants With Anti-HBs Seroconversion at Month 12 [Month 12]

    The measurements of anti-HBs antibodies were determined quantitatively by CMIA( Chemiluminescent Microparticle Immunoassay ) . The accepted protective serum anti-HBs level was ≥10 mIU/ml

  4. Occurrence of Adverse Events After Vaccination [Within 7 days after the vaccination, at Month 0, 1, and 6]

    Occurrence of adverse reactions within 7 days after vaccination with the hepatitis B vaccine

  5. Occurrence of Adverse Events After Vaccination [Within 28 days after the vaccination, at Month 0, 1, and 6]

    Occurrence of adverse reactions within 28 days after vaccination with the hepatitis B vaccine

  6. Anti-HBs Concentration at Month 18 [Month 18]

    The measurements of anti-HBs antibodies were determined quantitatively by CMIA( Chemiluminescent Microparticle Immunoassay )

  7. Number and Rate of Participants With Anti-HBs Seroconversion at Month 18 [Month 18]

    The measurements of anti-HBs antibodies were determined quantitatively by CMIA( Chemiluminescent Microparticle Immunoassay ) . The accepted protective serum anti-HBs level was ≥10 mIU/ml

  8. Anti-HBs Concentration at Month 30 [Month 30]

    The measurements of anti-HBs antibodies were determined quantitatively by CMIA( Chemiluminescent Microparticle Immunoassay )

  9. Number and Rate of Participants With Anti-HBs Seroconversion at Month 30 [Month 30]

    The measurements of anti-HBs antibodies were determined quantitatively by CMIA( Chemiluminescent Microparticle Immunoassay ) . The accepted protective serum anti-HBs level was ≥10 mIU/ml

  10. Anti-HBs Concentration at Month 42 [Month 42]

    The measurements of anti-HBs antibodies were determined quantitatively by CMIA( Chemiluminescent Microparticle Immunoassay )

  11. Number and Rate of Participants With Anti-HBs Seroconversion at Month 42 [Month 42]

    The measurements of anti-HBs antibodies were determined quantitatively by CMIA( Chemiluminescent Microparticle Immunoassay ) . The accepted protective serum anti-HBs level was ≥10 mIU/ml

Other Outcome Measures

  1. Number and Rate of Participants With Anti-HBs High-level Response at Month 7 [Month 7]

    The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/ml were high-level response.

  2. Number and Rate of Participants With Anti-HBs High-level Response at Month 12 [Month 12]

    The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.

  3. Number and Rate of Participants With Anti-HBs High-level Response at Month 18 [Month 18]

    The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.

  4. Number and Rate of Participants With Anti-HBs High-level Response at Month 30 [Month 30]

    The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.

  5. Number and Rate of Participants With Anti-HBs High-level Response at Month 42 [Month 42]

    The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Aged between 18 and 70 years at the enrolment

  • Serologically negative for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) at enrollment

  • Willing to adhere to the study protocol

Exclusion Criteria:
  • Being pregnant

  • Intolerance or allergy to any component of the vaccine

  • Any vaccination during the month preceding enrollment

  • Ongoing opportunistic infection

  • Liver disease

  • Hematological disorder

  • Cancer

  • Unexplained fever the week before enrollment

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Shanxi Medical University
  • Centers for Disease Control and Prevention, China

Investigators

  • Principal Investigator: Suping Wang, Shanxi Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Suping Wang, Professor, Shanxi Medical University
ClinicalTrials.gov Identifier:
NCT02991599
Other Study ID Numbers:
  • 2012ZX10002001003004003
First Posted:
Dec 13, 2016
Last Update Posted:
Dec 23, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Suping Wang, Professor, Shanxi Medical University
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title IM 20μg Group IM 60μg Group
Arm/Group Description Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Period Title: Overall Study
STARTED 98 98
COMPLETED 60 61
NOT COMPLETED 38 37

Baseline Characteristics

Arm/Group Title IM 20μg Group IM 60μg Group Total
Arm/Group Description Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6. Total of all reporting groups
Overall Participants 98 98 196
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
42.5
(7.5)
44.0
(7.5)
43.2
(7.5)
Sex: Female, Male (Count of Participants)
Female
23
23.5%
18
18.4%
41
20.9%
Male
75
76.5%
80
81.6%
155
79.1%
Race/Ethnicity, Customized (Count of Participants)
Han ethnicity
76
77.6%
83
84.7%
159
81.1%
minority ethnicity
22
22.4%
15
15.3%
37
18.9%
Region of Enrollment (Count of Participants)
Urban
76
77.6%
81
82.7%
157
80.1%
Rural
22
22.4%
17
17.3%
39
19.9%

Outcome Measures

1. Primary Outcome
Title Number and Rate of Participants With Anti-HBs Seroconversion at Month 7
Description The measurements of anti-HBs antibodies were determined quantitatively by CMIA( Chemiluminescent Microparticle Immunoassay ) . The accepted protective serum anti-HBs level was ≥10 mIU/ml.
Time Frame Month 7

Outcome Measure Data

Analysis Population Description
73 and 71 patients in the IM20 and IM60 groups completed the followed-up at months 7.
Arm/Group Title IM 20μg Group IM 60μg Group
Arm/Group Description Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Measure Participants 73 71
Count of Participants [Participants]
59
60.2%
62
63.3%
2. Secondary Outcome
Title Anti-HBs Concentration at Month 7
Description The measurements of anti-HBs antibodies were determined quantitatively by CMIA( Chemiluminescent Microparticle Immunoassay )
Time Frame Month 7

Outcome Measure Data

Analysis Population Description
73 and 71 patients in the IM20 and IM60 groups completed the followed-up at months 7 .
Arm/Group Title IM 20μg Group IM 60μg Group
Arm/Group Description Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Measure Participants 73 71
Mean (95% Confidence Interval) [mIU/mL]
630.4
742.9
3. Secondary Outcome
Title Anti-HBs Concentration at Month 12
Description The measurements of anti-HBs antibodies were determined quantitatively by CMIA( Chemiluminescent Microparticle Immunoassay )
Time Frame Month 12

Outcome Measure Data

Analysis Population Description
60 and 61 patients in the IM20 and IM60 groups completed the followed-up at months 12.
Arm/Group Title IM 20μg Group IM 60μg Group
Arm/Group Description Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Measure Participants 60 61
Mean (95% Confidence Interval) [mIU/mL]
125.9
182.2
4. Secondary Outcome
Title Number and Rate of Participants With Anti-HBs Seroconversion at Month 12
Description The measurements of anti-HBs antibodies were determined quantitatively by CMIA( Chemiluminescent Microparticle Immunoassay ) . The accepted protective serum anti-HBs level was ≥10 mIU/ml
Time Frame Month 12

Outcome Measure Data

Analysis Population Description
60 and 61 patients in the IM20 and IM60 groups completed the followed-up at months 12.
Arm/Group Title IM 20μg Group IM 60μg Group
Arm/Group Description Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Measure Participants 60 61
Count of Participants [Participants]
41
41.8%
43
43.9%
5. Secondary Outcome
Title Occurrence of Adverse Events After Vaccination
Description Occurrence of adverse reactions within 7 days after vaccination with the hepatitis B vaccine
Time Frame Within 7 days after the vaccination, at Month 0, 1, and 6

Outcome Measure Data

Analysis Population Description
196 patients were enrolled and randomized,195 patients received the first dose, 1 patients declined in IM60 group.
Arm/Group Title IM 20μg Group IM 60μg Group
Arm/Group Description Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Measure Participants 98 97
Count of Participants [Participants]
7
7.1%
8
8.2%
6. Secondary Outcome
Title Occurrence of Adverse Events After Vaccination
Description Occurrence of adverse reactions within 28 days after vaccination with the hepatitis B vaccine
Time Frame Within 28 days after the vaccination, at Month 0, 1, and 6

Outcome Measure Data

Analysis Population Description
196 patients were enrolled and randomized,195 patients received the first dose, 1 patients declined in IM60 group.
Arm/Group Title IM 20μg Group IM 60μg Group
Arm/Group Description Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Measure Participants 98 97
Count of Participants [Participants]
2
2%
3
3.1%
7. Other Pre-specified Outcome
Title Number and Rate of Participants With Anti-HBs High-level Response at Month 7
Description The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/ml were high-level response.
Time Frame Month 7

Outcome Measure Data

Analysis Population Description
73 and 71 patients in the IM20 and IM60 groups completed the followed-up at months 7.
Arm/Group Title IM 20μg Group IM 60μg Group
Arm/Group Description Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Measure Participants 73 71
Count of Participants [Participants]
31
31.6%
40
40.8%
8. Other Pre-specified Outcome
Title Number and Rate of Participants With Anti-HBs High-level Response at Month 12
Description The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.
Time Frame Month 12

Outcome Measure Data

Analysis Population Description
60 and 61 patients in the IM20 and IM60 groups completed the followed-up at months 12.
Arm/Group Title IM 20μg Group IM 60μg Group
Arm/Group Description Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Measure Participants 60 61
Count of Participants [Participants]
13
13.3%
20
20.4%
9. Secondary Outcome
Title Anti-HBs Concentration at Month 18
Description The measurements of anti-HBs antibodies were determined quantitatively by CMIA( Chemiluminescent Microparticle Immunoassay )
Time Frame Month 18

Outcome Measure Data

Analysis Population Description
47 and 43 patients in the IM20 and IM60 groups completed the followed-up at months 12.
Arm/Group Title IM 20μg Group IM 60μg Group
Arm/Group Description Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Measure Participants 47 43
Mean (95% Confidence Interval) [mIU/mL]
382.2
490.5
10. Secondary Outcome
Title Number and Rate of Participants With Anti-HBs Seroconversion at Month 18
Description The measurements of anti-HBs antibodies were determined quantitatively by CMIA( Chemiluminescent Microparticle Immunoassay ) . The accepted protective serum anti-HBs level was ≥10 mIU/ml
Time Frame Month 18

Outcome Measure Data

Analysis Population Description
47 and 43 patients in the IM20 and IM60 groups completed the followed-up at months 12.
Arm/Group Title IM 20μg Group IM 60μg Group
Arm/Group Description Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Measure Participants 47 43
Count of Participants [Participants]
29
29.6%
29
29.6%
11. Other Pre-specified Outcome
Title Number and Rate of Participants With Anti-HBs High-level Response at Month 18
Description The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.
Time Frame Month 18

Outcome Measure Data

Analysis Population Description
47 and 43 patients in the IM20 and IM60 groups completed the followed-up at months 12.
Arm/Group Title IM 20μg Group IM 60μg Group
Arm/Group Description Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Measure Participants 47 43
Count of Participants [Participants]
9
9.2%
14
14.3%
12. Secondary Outcome
Title Anti-HBs Concentration at Month 30
Description The measurements of anti-HBs antibodies were determined quantitatively by CMIA( Chemiluminescent Microparticle Immunoassay )
Time Frame Month 30

Outcome Measure Data

Analysis Population Description
46 and 42 patients in the IM20 and IM60 groups completed the followed-up at months 12.
Arm/Group Title IM 20μg Group IM 60μg Group
Arm/Group Description Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Measure Participants 46 42
Mean (95% Confidence Interval) [mIU/mL]
239.9
306.4
13. Secondary Outcome
Title Number and Rate of Participants With Anti-HBs Seroconversion at Month 30
Description The measurements of anti-HBs antibodies were determined quantitatively by CMIA( Chemiluminescent Microparticle Immunoassay ) . The accepted protective serum anti-HBs level was ≥10 mIU/ml
Time Frame Month 30

Outcome Measure Data

Analysis Population Description
46 and 42 patients in the IM20 and IM60 groups completed the followed-up at months 12.
Arm/Group Title IM 20μg Group IM 60μg Group
Arm/Group Description Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Measure Participants 46 42
Count of Participants [Participants]
20
20.4%
25
25.5%
14. Secondary Outcome
Title Anti-HBs Concentration at Month 42
Description The measurements of anti-HBs antibodies were determined quantitatively by CMIA( Chemiluminescent Microparticle Immunoassay )
Time Frame Month 42

Outcome Measure Data

Analysis Population Description
45 and 40 patients in the IM20 and IM60 groups completed the followed-up at months 12.
Arm/Group Title IM 20μg Group IM 60μg Group
Arm/Group Description Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Measure Participants 45 40
Mean (95% Confidence Interval) [mIU/mL]
88.6
97.7
15. Secondary Outcome
Title Number and Rate of Participants With Anti-HBs Seroconversion at Month 42
Description The measurements of anti-HBs antibodies were determined quantitatively by CMIA( Chemiluminescent Microparticle Immunoassay ) . The accepted protective serum anti-HBs level was ≥10 mIU/ml
Time Frame Month 42

Outcome Measure Data

Analysis Population Description
45 and 40 patients in the IM20 and IM60 groups completed the followed-up at months 12.
Arm/Group Title IM 20μg Group IM 60μg Group
Arm/Group Description Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Measure Participants 45 40
Count of Participants [Participants]
14
14.3%
20
20.4%
16. Other Pre-specified Outcome
Title Number and Rate of Participants With Anti-HBs High-level Response at Month 30
Description The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.
Time Frame Month 30

Outcome Measure Data

Analysis Population Description
46 and 42 patients in the IM20 and IM60 groups completed the followed-up at months 12.
Arm/Group Title IM 20μg Group IM 60μg Group
Arm/Group Description Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Measure Participants 46 42
Count of Participants [Participants]
6
6.1%
11
11.2%
17. Other Pre-specified Outcome
Title Number and Rate of Participants With Anti-HBs High-level Response at Month 42
Description The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.
Time Frame Month 42

Outcome Measure Data

Analysis Population Description
45 and 40 patients in the IM20 and IM60 groups completed the followed-up at months 12.
Arm/Group Title IM 20μg Group IM 60μg Group
Arm/Group Description Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
Measure Participants 45 40
Count of Participants [Participants]
4
4.1%
8
8.2%

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group Title IM 20μg Group IM 60μg Group
Arm/Group Description Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
All Cause Mortality
IM 20μg Group IM 60μg Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/98 (0%) 0/97 (0%)
Serious Adverse Events
IM 20μg Group IM 60μg Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/98 (0%) 0/97 (0%)
Other (Not Including Serious) Adverse Events
IM 20μg Group IM 60μg Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 7/98 (7.1%) 8/97 (8.2%)
Musculoskeletal and connective tissue disorders
pain 4/98 (4.1%) 5/97 (5.2%)
Skin and subcutaneous tissue disorders
Erythema 5/98 (5.1%) 5/97 (5.2%)
Edema 3/98 (3.1%) 4/97 (4.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Suping Wang, PhD
Organization Shanxi Medical University
Phone #86-351-4135103
Email spwang88@163.com
Responsible Party:
Suping Wang, Professor, Shanxi Medical University
ClinicalTrials.gov Identifier:
NCT02991599
Other Study ID Numbers:
  • 2012ZX10002001003004003
First Posted:
Dec 13, 2016
Last Update Posted:
Dec 23, 2021
Last Verified:
Nov 1, 2021