Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02175758
Registration number
NCT02175758
Ethics application status
Date submitted
24/06/2014
Date registered
26/06/2014
Date last updated
30/04/2019
Titles & IDs
Public title
Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection
Query!
Scientific title
A Phase 2, Open-Label, Multicenter, Multi-cohort, Single-Arm Study to Investigate the Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection
Query!
Secondary ID [1]
0
0
2014-002283-32
Query!
Secondary ID [2]
0
0
GS-US-334-1112
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Hepatitis C Virus Infection
0
0
Query!
Condition category
Condition code
Infection
0
0
0
0
Query!
Studies of infection and infectious agents
Query!
Infection
0
0
0
0
Query!
Other infectious diseases
Query!
Infection
0
0
0
0
Query!
Sexually transmitted infections
Query!
Oral and Gastrointestinal
0
0
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - SOF
Treatment: Drugs - RBV
Experimental: 12 to < 18 Years Old, SOF+RBV 12 Weeks (GT 2) - Participants between 12 to \< 18 years of age with genotype (GT) 2 HCV infection weighing = 45 kg will receive SOF (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules based on swallowability assessment during screening) plus RBV (up to 1400 mg) for 12 weeks.
Experimental: 12 to < 18 Years Old, SOF+RBV 24 Weeks (GT 3) - Participants between 12 to \< 18 years of age with genotype 3 HCV infection weighing = 45 kg will receive SOF (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules based on swallowability assessment during screening) plus RBV (up to 1400 mg) for 24 weeks.
Experimental: 6 to < 12 Years Old, SOF+RBV 12 Weeks (GT 2) - Participants between 6 to \< 12 years of age with genotype 2 HCV infection weighing = 17 kg and \< 45 kg will receive SOF (2 x 100 mg tablets or 4 x 50 mg oral granules based on swallowability assessment during screening) plus RBV (up to 1400 mg) for 12 weeks.
Experimental: 6 to <12 Years Old, SOF+RBV 24 Weeks (GT 3) - Participants between 6 to \< 12 years of age with genotype 3 HCV infection weighing = 17 kg and \< 45 kg will receive SOF (2 x 100 mg tablets or 4 x 50 mg oral granules based on swallowability assessment during screening) plus RBV (up to 1400 mg) for 24 weeks.
Experimental: 3 to < 6 Years Old, SOF+RBV 12 Weeks (GT 2) - Participants between 3 to \< 6 years of age with genotype 2 HCV infection weighing = 17kg will receive SOF (4 x 50 mg oral granules) plus RBV (up to 1400 mg) for 12 weeks and those weighing \< 17 kg will receive SOF (3 x 50 mg oral granules) + RBV (up to 1400 mg) for 12 weeks.
Experimental: 3 to < 6 Years Old, SOF+RBV 24 Weeks (GT 3) - Participants between 3 to \< 6 years of age with genotype 2 HCV infection weighing = 17kg will receive SOF (4 x 50 mg oral granules) plus RBV (up to 1400 mg) for 24 weeks and those weighing \< 17 kg will receive SOF (3 x 50 mg oral granules) + RBV (up to 1400 mg) for 24 weeks.
Treatment: Drugs: SOF
SOF administered orally once daily
Treatment: Drugs: RBV
RBV oral solution or capsules will be administered orally in a divided daily dose based on weight
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF)
Query!
Assessment method [1]
0
0
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Query!
Timepoint [1]
0
0
6 to < 18 years of age: predose, 0.5, 1, 2, 3, 4, 8, and 12 hours postdose on Day 7; 3 to < 6 years of age: predose, 2, 4, 8, and 12 hours postdose on Day 7
Query!
Primary outcome [2]
0
0
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
Up to 24 weeks
Query!
Primary outcome [3]
0
0
For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12)
Query!
Assessment method [3]
0
0
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Query!
Timepoint [3]
0
0
Posttreatment Week 12
Query!
Secondary outcome [1]
0
0
For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Baseline; Weeks 1, 2, 4, 8, and 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)
Query!
Secondary outcome [2]
0
0
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
Up to Day 7
Query!
Secondary outcome [3]
0
0
For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4)
Query!
Assessment method [3]
0
0
SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment.
Query!
Timepoint [3]
0
0
Posttreatment Week 4
Query!
Secondary outcome [4]
0
0
For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
Query!
Assessment method [4]
0
0
SVR24 was defined as HCV RNA \< LLOQ at 24 weeks after stopping study treatment.
Query!
Timepoint [4]
0
0
Posttreatment Week 24
Query!
Secondary outcome [5]
0
0
For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough
Query!
Assessment method [5]
0
0
Viral breakthrough was defined as having confirmed HCV RNA = LLOQ after having previously had HCV RNA \< LLOQ while on treatment.
Query!
Timepoint [5]
0
0
Up to 24 weeks
Query!
Secondary outcome [6]
0
0
For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse
Query!
Assessment method [6]
0
0
Viral relapse was defined as having confirmed HCV RNA = LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.
Query!
Timepoint [6]
0
0
Up to Posttreatment Week 24
Query!
Secondary outcome [7]
0
0
For the Treatment Phase, Change From Baseline in HCV RNA
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)
Query!
Secondary outcome [8]
0
0
For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment
Query!
Assessment method [8]
0
0
Query!
Timepoint [8]
0
0
Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)
Query!
Secondary outcome [9]
0
0
For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization
Query!
Assessment method [9]
0
0
ALT normalization was defined as ALT \> the upper limit of normal (ULN) at baseline and ALT = ULN at each visit. One participant in the 3 to \< 6 Years Old 12 Weeks group had ALT \> ULN at Baseline, but had no other available data.
Query!
Timepoint [9]
0
0
Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Week 4
Query!
Secondary outcome [10]
0
0
For the Treatment Phase, Change From Baseline in Height
Query!
Assessment method [10]
0
0
Query!
Timepoint [10]
0
0
Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24
Query!
Secondary outcome [11]
0
0
For the Treatment Phase, Change From Baseline in Weight
Query!
Assessment method [11]
0
0
Query!
Timepoint [11]
0
0
Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24
Query!
Secondary outcome [12]
0
0
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair
Query!
Assessment method [12]
0
0
Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.
Query!
Timepoint [12]
0
0
Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24
Query!
Secondary outcome [13]
0
0
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development
Query!
Assessment method [13]
0
0
Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.
Query!
Timepoint [13]
0
0
Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24
Query!
Secondary outcome [14]
0
0
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair
Query!
Assessment method [14]
0
0
Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.
Query!
Timepoint [14]
0
0
Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24
Query!
Secondary outcome [15]
0
0
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development
Query!
Assessment method [15]
0
0
Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.
Query!
Timepoint [15]
0
0
Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24
Query!
Secondary outcome [16]
0
0
For the Treatment Phase, Palatability of SOF Granules at Day 1 as Assessed by the Percentage of Participants Able/Unable to Taste the SOF Oral Granules
Query!
Assessment method [16]
0
0
Participants were asked if they were able to taste the SOF oral granules.
Query!
Timepoint [16]
0
0
Day 1
Query!
Eligibility
Key inclusion criteria
Key
* Consent of parent or legal guardian required
* Chronic HCV infection genotype 2 or 3
* Screening laboratory values within defined thresholds
* PK Lead-in only: all individuals must be treatment naive
Key
Query!
Minimum age
3
Years
Query!
Query!
Maximum age
17
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
* Co-infection with HIV, acute hepatitis A virus, or hepatitis B virus
* Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage)
* Pregnant or nursing females
* Known hypersensitivity to study medication
* Use of any prohibited concomitant medications as within 28 days of the Day 1 visit
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
7/07/2014
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
13/09/2018
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
106
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Query!
Recruitment hospital [1]
0
0
- Westmead
Query!
Recruitment hospital [2]
0
0
- Melbourne
Query!
Recruitment hospital [3]
0
0
- New Lambton Heights
Query!
Recruitment postcode(s) [1]
0
0
- Westmead
Query!
Recruitment postcode(s) [2]
0
0
- Melbourne
Query!
Recruitment postcode(s) [3]
0
0
- New Lambton Heights
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
District of Columbia
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Georgia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Indiana
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Maryland
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Massachusetts
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
New York
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Ohio
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Pennsylvania
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Tennessee
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Texas
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Washington
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
West Virginia
Query!
Country [15]
0
0
Belgium
Query!
State/province [15]
0
0
Brussels
Query!
Country [16]
0
0
Germany
Query!
State/province [16]
0
0
Nordrhein-westfalen
Query!
Country [17]
0
0
Germany
Query!
State/province [17]
0
0
Berlin
Query!
Country [18]
0
0
Italy
Query!
State/province [18]
0
0
Bologna
Query!
Country [19]
0
0
Italy
Query!
State/province [19]
0
0
Firenze
Query!
Country [20]
0
0
Italy
Query!
State/province [20]
0
0
Milano
Query!
Country [21]
0
0
Italy
Query!
State/province [21]
0
0
Padova
Query!
Country [22]
0
0
Italy
Query!
State/province [22]
0
0
San Giovanni Rotondo
Query!
Country [23]
0
0
Italy
Query!
State/province [23]
0
0
Torino
Query!
Country [24]
0
0
New Zealand
Query!
State/province [24]
0
0
Auckland
Query!
Country [25]
0
0
Russian Federation
Query!
State/province [25]
0
0
Moscow
Query!
Country [26]
0
0
Russian Federation
Query!
State/province [26]
0
0
Novokuznetsk
Query!
Country [27]
0
0
Russian Federation
Query!
State/province [27]
0
0
Saint-Petersburg
Query!
Country [28]
0
0
Russian Federation
Query!
State/province [28]
0
0
Tolyatti
Query!
Country [29]
0
0
United Kingdom
Query!
State/province [29]
0
0
Birmingham
Query!
Country [30]
0
0
United Kingdom
Query!
State/province [30]
0
0
Leeds
Query!
Country [31]
0
0
United Kingdom
Query!
State/province [31]
0
0
London
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Gilead Sciences
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This study will have two parts as follows: The PK Lead-in Phase of the study will evaluate the steady state pharmacokinetics (PK) and confirm the dose of sofosbuvir (SOF) in hepatitis C virus (HCV)-infected pediatric participants. The PK Lead-in Phase will also evaluate the safety and tolerability of 7 days of dosing of SOF+ribavirin (RBV) in HCV-infected pediatric participants. The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate SOF dosage levels. Participants from the PK Lead-in Phase will immediately rollover into the Treatment Phase with no interruption of study drug administration. The Treatment Phase will evaluate the antiviral efficacy, safety, and tolerability of SOF+RBV for 12 or 24 weeks in pediatric participants with genotype 2 or 3 HCV infection, respectively.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02175758
Query!
Trial related presentations / publications
Kirby B, German P, Kanwar B, Ni L, Lakatos I, Ling J, Mathias A. Pharmacokinetics of Once-Daily Sofosbuvir and Ledipasvir/Sofosbuvir in HCV-Infected Adolescents [Poster 1707]. American Association for the Study of Liver Diseases (AASLD); 2015 November 13-17, San Francisco, USA. Hepatology 2015;62 (S1): 1040A-1041A Garrison KL, Mathias A, Kersey K, Kanwar B, Ni L, Jain A, et al. Pharmacokinetics of Once-Daily Sofosbuvir and Ledipasvir/Sofosbuvir in HCV-Infected Pediatrics Aged 6 to <12 Years Old [Poster 878]. American Association for the Study of Liver Diseases (AASLD); 2016 11-15 November; Boston, MA. Hepatology 2016;64 (S1): 436A Schwarz KB, Rosenthal P, Gonzales-Peralta RP, Jonas MM, Balistreri WF, Lin CH, et al. Sofosbuvir + Ribavirin for 12 or 24 Weeks Is Safe and Effective in Adolescents with Genotype 2 or Genotype 3 Chronic Hepatitis C Infection. Hepatology 2016; 63 (Suppl 1): abstract 706. Wirth S, Rosenthal P, Gonzalez-Peralta RP, Jonas MM, Balistreri WF, Lin CH, Hardikar W, Kersey K, Massetto B, Kanwar B, Brainard DM, Shao J, Svarovskaia E, Kirby B, Arnon R, Murray KF, Schwarz KB. Sofosbuvir and ribavirin in adolescents 12-17 years old with hepatitis C virus genotype 2 or 3 infection. Hepatology. 2017 Oct;66(4):1102-1110. doi: 10.1002/hep.29278. Epub 2017 Aug 26. Younossi ZM, Stepanova M, Schwarz KB, Wirth S, Rosenthal P, Gonzalez-Peralta R, Murray K, Henry L, Hunt S. Quality of life in adolescents with hepatitis C treated with sofosbuvir and ribavirin. J Viral Hepat. 2018 Apr;25(4):354-362. doi: 10.1111/jvh.12830. Epub 2017 Dec 26. Rosenthal P, Schwarz KB, Gonzales-Peralta RP, Lin CH, Kelly DA, Nightingale S, et al. Sofosbuvir + Ribavirin for 12 or 24 Weeks Is Safe and Effective in Children 3 to <12 Years Old with Genotype 2 or Genotype 3 Chronic Hepatitis C Infection. Hepatology 2018; 68 (Suppl 1): abstract 1844. Rosenthal P, Schwarz KB, Gonzalez-Peralta RP, Lin CH, Kelly DA, Nightingale S, Balistreri WF, Bansal S, Jonas MM, Massetto B, Brainard DM, Hsueh CH, Shao J, Parhy B, Davison S, Feiterna-Sperling C, Gillis LA, Indolfi G, Sokal EM, Murray KF, Wirth S. Sofosbuvir and Ribavirin Therapy for Children Aged 3 to <12 Years With Hepatitis C Virus Genotype 2 or 3 Infection. Hepatology. 2020 Jan;71(1):31-43. doi: 10.1002/hep.30821. Epub 2019 Aug 13.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Gilead Study Director
Query!
Address
0
0
Gilead Sciences
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol: Original
https://cdn.clinicaltrials.gov/large-docs/58/NCT02175758/Prot_000.pdf
Study protocol
Study Protocol: Amendment 1
https://cdn.clinicaltrials.gov/large-docs/58/NCT02175758/Prot_001.pdf
Study protocol
Study Protocol: Amendment 2
https://cdn.clinicaltrials.gov/large-docs/58/NCT02175758/Prot_002.pdf
Study protocol
Study Protocol: Amendment 3
https://cdn.clinicaltrials.gov/large-docs/58/NCT02175758/Prot_003.pdf
Study protocol
Study Protocol: Amendment 4
https://cdn.clinicaltrials.gov/large-docs/58/NCT02175758/Prot_004.pdf
Study protocol
Study Protocol: Amendment 5
https://cdn.clinicaltrials.gov/large-docs/58/NCT02175758/Prot_005.pdf
Study protocol
Study Protocol: Amendment 6
https://cdn.clinicaltrials.gov/large-docs/58/NCT02175758/Prot_006.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/58/NCT02175758/SAP_007.pdf
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Kirby B, German P, Kanwar B, Ni L, Lakatos I, Ling...
[
More Details
]
Journal
Garrison KL, Mathias A, Kersey K, Kanwar B, Ni L, ...
[
More Details
]
Journal
Schwarz KB, Rosenthal P, Gonzales-Peralta RP, Jona...
[
More Details
]
Journal
Wirth S, Rosenthal P, Gonzalez-Peralta RP, Jonas M...
[
More Details
]
Journal
Younossi ZM, Stepanova M, Schwarz KB, Wirth S, Ros...
[
More Details
]
Journal
Rosenthal P, Schwarz KB, Gonzales-Peralta RP, Lin ...
[
More Details
]
Results are available at
https://clinicaltrials.gov/study/NCT02175758
Download to PDF