A Study to Investigate the Safety and Efficacy of Fidaxomicin (Oral Suspension or Tablets) and Vancomycin (Oral Liquid or Capsules) in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD) (SUNSHINE)

A Phase 3, Multicenter, Investigator-blind, Randomized, Parallel Group Study to Investigate the Safety and Efficacy of Fidaxomicin Oral Suspension or Tablets Taken q12h, and Vancomycin Oral Liquid or Capsules Taken q6h, for 10 Days in Pediatric Subjects With Clostridium Difficile-associated Diarrhea

The purpose of this study was to investigate the clinical response to fidaxomicin oral suspension or tablets and vancomycin oral liquid or capsules in pediatric participants with Clostridium difficile-associated diarrhea (CDAD). It also investigated the recurrence/sustained clinical response to and safety of fidaxomicin and vancomycin, as well as acceptance of the fidaxomicin oral suspension formulation.

Study Overview

• Status: Completed
• Conditions: Clostridium Difficile-associated Diarrhea (CDAD)
• Intervention / Treatment: Drug: Fidaxomicin oral suspension; Drug: Fidaxomicin tablets; Drug: Vancomycin oral liquid; Drug: Vancomycin capsules

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium, 9000
    • Site BE32003
  • Liege, Belgium, 4020
    • Site BE32002
  • Flemish Brabant
    • Brussels, Flemish Brabant, Belgium, 1200
      • Site BE32001
• Canada
  • Ontario
    • Oshawa, Ontario, Canada, L1G 2B9
      • Site CA15003
• France
  • La Tronche, France, 38700
    • Site FR33002
  • Nice, France, 06200
    • Site FR33001
  • Nice, France, 06200
    • Site FR33007
  • Paris, France, 75012
    • Site FR33005
  • Strasbourg cedex, France, 67098
    • Site FR33008
• Germany
  • Essen, Germany, 45122
    • Site DE49010
  • Frankfurt am M., Germany, 60596
    • Site DE49002
  • Freiburg, Germany, 79106
    • Site DE49006
  • Mainz, Germany, 55131
    • Site DE49004
  • Muenster, Germany, 48149
    • Site DE49001
  • Saint Augustin, Germany, 53757
    • Site DE49003
• Hungary
  • Budapest, Hungary, 1097
    • Site HU36006
  • Szeged, Hungary, 6720
    • Site HU36004
• Italy
  • Milano, Italy, 20122
    • Site IT39004
  • Roma, Italy, 165
    • SIte IT39001
• Poland
  • Bialystok, Poland, 15 -274
    • Site PL48012
  • Bydgoszcz, Poland, 85-030
    • Site PL48007
  • Debica, Poland, 39-200
    • Site PL48004
  • Rzeszow, Poland, 35-210
    • Site PL48014
  • Tarnow, Poland, 33-100
    • Site PL48006
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 04-730
      • Site PL48002
• Romania
  • Bucharest, Romania
    • Site RO40005
• Spain
  • Barcelona, Spain, 8950
    • Site ES34002
  • Madrid, Spain, 28009
    • Site ES34007
  • Madrid, Spain, 28046
    • Site ES34004
  • Valencia, Spain, 46026
    • Site ES34003
• United States
  • California
    • Orange, California, United States, 92868
      • Site US10015
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Site US10010
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Site US10004
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Site US10025
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Site US10032
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Site US10030
  • New York
    • Stony Brook, New York, United States, 11794-8111
      • Site US10008
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Site US10028
  • Ohio
    • Cincinnati, Ohio, United States, 45229-3039
      • Site US10027
    • Toledo, Ohio, United States, 43606
      • Site US10014
  • Tennessee
    • Johnson City, Tennessee, United States, 37604
      • Site US10034
    • Memphis, Tennessee, United States, 38105-2794
      • Site US10022
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Site US10038
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • Site US10037

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject is diagnosed with CDAD according to local diagnostic criteria. As a minimum there must be positive detection, within 72 hours prior to randomization, of either toxin A and/or toxin B in stool or positive detection of toxigenic C. difficile in stool and:

  • Subject from Birth to < 2 years: watery diarrhea in the 24 hours prior to screening.
  • Subject ≥ 2 years to < 18 years: ≥ 3 unformed bowel movements in the 24 hours prior to screening.
  • Male and female subjects aged from birth to < 18 years: Note that in the United States of America subjects can only be included if aged ≥ 6 months to < 18 years.
• For subjects < 5 years: Negative rotavirus test.

• Female subject of childbearing potential:

  • must have a negative urine pregnancy test at Screening, and
  • must abstain from sexual activity for the duration of the study, or
  • must use two forms of birth control (at least one of which must be a barrier method) starting at Screening and throughout the study period and for 28 days after the final study drug administration.
• Female subject must not be breastfeeding at Screening or during the study period, and for 28 days after the final study drug administration.
• Female subject must not donate ova starting at Screening and throughout the study period, and for 28 days after the final study drug administration.
• Subject agrees not to participate in another interventional study while in the study (with the exception of studies as described in exclusion criteria below).

Exclusion Criteria:

• Concurrent use of metronidazole, oral vancomycin or any other antibiotic treatments for CDAD. If the investigator feels the clinical imperative is to begin treatment before knowing the laboratory result for toxigenic C. difficile, up to four doses but no more than 24 hours of treatment with metronidazole, oral vancomycin or any other effective treatment for CDAD are allowed.
• Subject has pseudomembranous colitis, fulminant colitis, toxic megacolon or ileus.
• Subject has a history of inflammatory bowel disease (e.g., ulcerative colitis or Crohn's disease etc.).
• Subject has diarrhea caused by an agent other than C. difficile (e.g. infections, infestations, drugs etc.).
• Subject has known hypersensitivity to fidaxomicin, vancomycin or their excipients or to teicoplanin.
• Subject has received an investigational therapy within 28 days, prior to Screening, with the exception of studies with primary treatment for cancer without novel Investigational Medicinal Product (IMP) and which do not affect the assessment of diarrhea.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fidaxomicin; Participants from birth to < 6 years of age received weight based doses of fidaxomicin oral suspension (32 mg/kg/day with a maximum dose of 400 mg/day divided in 2 doses) 2 times daily for 10 days. Participants aged ≥ 6 years to < 18 years of age received a 200 mg fidaxomicin tablet 2 times daily for 10 days.	Drug: Fidaxomicin oral suspension; Participants from birth to < 6 years of age received weight based doses of fidaxomicin oral suspension (32 mg/kg/day with a maximum dose of 400 mg/day divided in 2 doses) 2 times daily for 10 days.; Other Names: Dificid; Dificlir; Drug: Fidaxomicin tablets; Participants aged ≥ 6 years to < 18 years of age received a 200 mg fidaxomicin tablet 2 times daily for 10 days.; Other Names: Dificid; Dificlir
Active Comparator: Vancomycin; Participants from birth to < 6 years of age received weight based doses of vancomycin oral liquid (40 mg/kg/day with a maximum dose of 500 mg/day divided in 4 doses) 4 times daily for 10 days. Participants aged ≥ 6 years to < 18 years of age received a 125 mg vancomycin capsule 4 times daily for 10 days.	Drug: Vancomycin oral liquid; Participants from birth to < 6 years of age received weight based doses of vancomycin oral liquid (40 mg/kg/day with a maximum dose of 500 mg/day divided in 4 doses) 4 times daily for 10 days.; Drug: Vancomycin capsules; Participants aged ≥ 6 years to < 18 years of age received a 125 mg vancomycin capsule 4 times daily for 10 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Confirmed Clinical Response (CCR) at End of Treatment (EOT) +2 Days	Initial clinical response (ICR) for ages from birth to < 2 years was defined as absence of watery diarrhea for 2 consecutive treatment days, remaining well until study drug discontinuation. ICR for ages ≥ 2 years to < 18 years was defined as improvement in number and character of bowel movements as determined by < 3 unformed bowel movements (UBMs) per day for 2 consecutive treatment days, remaining well until study drug discontinuation. CCR was defined for both age groups as not requiring further CDAD therapy within 2 days after study drug completion, and was reported with a positive (Yes) or negative (No) outcome. Resolution of diarrhea was assessed during interviews of participant/parent/legal guardian, supplemented by review of personal records (if hospitalized) and checked for presence of watery diarrhea (ages from birth to < 2 years) or number of UBMs (for ages ≥ 2 years to < 18 years).	Up to day 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Sustained Clinical Response (SCR) at EOT +9 Days	SCR at EOT + 9 days was defined as CCR (EOT + 2 days) without CDAD recurrence until assessment at EOT +9 days during the follow-up period. Recurrence for ages from birth to < 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic Clostridium difficile (C. difficile) in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years < 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.	Up to day 19
Percentage of Participants With Global Cure (GC) at EOT +9 Days	GC was reported as a positive (Yes) or negative (No) outcome and was calculated using SCR and ICR/CCR values according to the following conditions: ● if ICR/CCR=Yes and SCR=Yes, then Global Cure was Yes. ● if ICR/CCR=Yes and SCR =No, then Global Cure was No. ● if ICR/CCR=No (SCR not assessed), then Global Cure was No. ● if ICR/CCR=Missing (SCR not assessed), then Global Cure was set to No. No multiple imputation method (MI) was used for global cure at EOT + 9 days.	Up to day 19
Percentage of Participants With Recurrence of CDAD at EOT +9 Days	Recurrence for ages from birth to < 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years < 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.	Up to day 19
Percentage of Participants With SCR at EOT +16 Days	SCR at EOT + 16 days was defined as CCR (EOT + 2 days) without CDAD recurrence until assessment at EOT + 16 days during the follow-up period. Recurrence for ages from birth to < 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years < 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.	Up to day 26
Percentage of Participants With GC at EOT +16 Days	GC was reported as a positive (Yes) or negative (No) outcome and was calculated using SCR and ICR/CCR values according to the following conditions: ● if ICR/CCR=Yes and SCR=Yes, then Global Cure was Yes. ● if ICR/CCR=Yes and SCR =No, then Global Cure was No. ● if ICR/CCR=No (SCR not assessed), then Global Cure was No. ● if ICR/CCR=Missing (SCR not assessed), then Global Cure was set to No. No multiple imputation method (MI) was used for global cure at EOT + 16 days.	Up to day 26
Percentage of Participants With Recurrence of CDAD at EOT +16 Days	Recurrence for ages from birth to < 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years < 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.	Up to day 26
Percentage of Participants With SCR at EOT +23 Days	SCR at EOT + 23 days was defined as CCR (EOT + 2 days) without CDAD recurrence until assessment at EOT + 16 days during the follow-up period. Recurrence for ages from birth to < 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years < 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.	Up to day 33
Percentage of Participants With GC at EOT +23 Days	GC was reported as a positive (Yes) or negative (No) outcome and was calculated using SCR and ICR/CCR values according to the following conditions: ● if ICR/CCR=Yes and SCR=Yes, then Global Cure was Yes. ● if ICR/CCR=Yes and SCR =No, then Global Cure was No. ● if ICR/CCR=No (SCR not assessed), then Global Cure was No. ● if ICR/CCR=Missing (SCR not assessed), then Global Cure was set to No. No multiple imputation method (MI) was used for global cure at EOT + 23 days.	Up to day 33
Percentage of Participants With Recurrence of CDAD at EOT +23 Days	Recurrence for ages from birth to < 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years < 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.	Up to day 33
Percentage of Participants With SCR at End of Study (EOS) (EOT +30 Days)	SCR at EOS was defined as CCR (EOT + 2 days) without CDAD recurrence until assessment at EOS (EOT + 30 days) during the follow-up period. Recurrence for ages from birth to < 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years < 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.	Up to day 40
Percentage of Participants With GC at EOS (EOT +30 Days)	GC was reported as a positive (Yes) or negative (No) outcome and was calculated using SCR and ICR/CCR values according to the following conditions: ● if ICR/CCR=Yes and SCR=Yes, then Global Cure was Yes. ● if ICR/CCR=Yes and SCR =No, then Global Cure was No. ● if ICR/CCR=No (SCR not assessed), then Global Cure was No. ● if ICR/CCR=Missing (SCR not assessed), then Global Cure was set to No. Global Cure at EOT +30 days was derived using MI in case ICR/CCR=Missing (SCR not assessed) following Rubin's multiple imputation method.	Up to day 40
Percentage of Participants With Recurrence of CDAD at EOS (EOT +30 Days)	Recurrence for ages from birth to < 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years < 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.	Up to day 40
Time to Resolution of Diarrhea (TTROD)	TTROD for ages from birth < 2 years was defined as time elapsing (hours rounded up from minutes > 30) from treatment start (time of first study drug dose) to diarrhea resolution (time of last episode of watery diarrhea the day prior to the first of 2 consecutive days without watery diarrhea sustained through EOT). TTROD for ages ≥ 2 years to < 18 years was defined as time elapsing (hours rounded up from minutes > 30) from treatment start (time of first dose) to diarrhea resolution (time of the last UBM the day prior to the first of 2 consecutive days of < 3 UBMs sustained through EOT). TTROD by Kaplan-Meier Method. Those who completed treatment but did not show diarrhea resolution until EOT were censored at Day 10/240 hours. Those who did not complete treatment, discontinued earlier but did not show diarrhea resolution until disc. day were censored at disc. (days converted to hours). Those whose diarrhea did not continue after first dose were included with a TTROD of 1 hour.	Up to day 10
Time to Recurrence of CDAD for Participants With CCR at EOT +2 Days	Time to recurrence was defined as the time (days) from CCR until the onset of recurrence. Time to recurrence of CDAD by Kaplan-Meier Method. Data for median was estimated and the 95% CI could not be estimated due to low event rate. Data not estimable denoted as NA. Participants with CCR at EOT+2 days, who completed the follow-up period but did not experience a recurrence of CDAD were censored at EOT+30 days and those who did not complete the follow-up period and discontinued during this period and did not experience a recurrence of CDAD were censored at day of discontinuation.	Up to day 40
Number of Participants With Adverse Events (AEs)	An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a study drug or who had undergone study procedures which did not necessarily have a causal relationship with this treatment. This included abnormal laboratory tests, vital signs, electrocardiogram data or physical examinations that were defined as AEs if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study drug or was clinically significant in the investigator's opinion. The following standard with 3 grades was used to measure the severity of AEs, including abnormal clinical laboratory values: ● Mild: No disruption of normal daily activities ● Moderate: Affected normal daily activities ● Severe: Inability to perform daily activities. A treatment-emergent adverse event (TEAE) was defined as an AE observed after starting administration of the test drug/comparative drug.	From the first dose of study drug administration up to 30 days after EOT (up to day 40)
Plasma Concentrations of Fidaxomicin	Drug concentration was derived from the blood samples collected.	Within 30 minutes predose and 1 to 5 hours postdose taken between day 5 and day 10
Plasma Concentrations of Metabolite OP-1118	Drug concentration was derived from the blood samples collected.	Within 30 minutes predose and 1 to 5 hours postdose taken between day 5 and day 10
Metabolite-to-Parent Ratio (MPRconc)	Drug concentration was derived from the blood samples collected.	Within 30 minutes predose and 1 to 5 hours postdose taken between day 5 and day 10
Fecal Concentrations of Fidaxomicin	Drug concentration was derived from the stool samples collected.	Within 24 hours of a dose taken between day 5 and day 10
Fecal Concentrations of Metabolite OP-1118	Drug concentration was derived from the stool samples collected.	Within 24 hours of a dose taken between day 5 and day 10
MPRconc Within 24 Hours of a Dose	Drug concentration was derived from the stool samples collected.	Within 24 hours of a dose taken between day 5 and day 10
Acceptance of Formulation (Palatability Assessment) in All Participants at First Administration of Study Drug and at Day 7	Acceptance of formulation was evaluated in all participants who received fidaxomicin oral suspension and vancomycin oral liquid (i.e., participants from birth to =< 6 years and participants > 6 years unable to swallow tablets) by means of a five-point rating scale (awful, poor, fair, good, excellent) by unblinded staff if hospitalized, and by the participant/parents/legal guardian when at home.	Days 1 and 7

Collaborators and Investigators

• Sponsor: Astellas Pharma Europe B.V.
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Study Director: Clinical Research Physician, Astellas Pharma Europe B.V.

Publications and helpful links

General Publications

• Wolf J, Kalocsai K, Fortuny C, Lazar S, Bosis S, Korczowski B, Petit A, Bradford D, Croos-Dabrera R, Incera E, Melis J, van Maanen R. Safety and Efficacy of Fidaxomicin and Vancomycin in Children and Adolescents with Clostridioides (Clostridium) difficile Infection: A Phase 3, Multicenter, Randomized, Single-blind Clinical Trial (SUNSHINE). Clin Infect Dis. 2020 Dec 17;71(10):2581-2588. doi: 10.1093/cid/ciz1149.
• Borali E, De Giacomo C. Clostridium Difficile Infection in Children: A Review. J Pediatr Gastroenterol Nutr. 2016 Dec;63(6):e130-e140. doi: 10.1097/MPG.0000000000001264.

Helpful Links

• Link to results on Astellas Clinical Study Results website

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2015
• Primary Completion (Actual): March 7, 2018
• Study Completion (Actual): March 7, 2018

Study Registration Dates

• First Submitted: August 11, 2014
• First Submitted That Met QC Criteria: August 14, 2014
• First Posted (Estimate): August 18, 2014

Study Record Updates

• Last Update Posted (Actual): March 23, 2020
• Last Update Submitted That Met QC Criteria: March 10, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: vancomycin; Clostridium difficile infection; fidaxomicin; Clostridium difficile-associated Diarrhea (CDAD)
• Additional Relevant MeSH Terms: Infections; Signs and Symptoms, Digestive; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Diarrhea; Clostridium Infections; Anti-Infective Agents; Anti-Bacterial Agents; Vancomycin; Fidaxomicin
• Other Study ID Numbers: 2819-CL-0202; 2013-000508-40 (EudraCT Number); SUNSHINE (Acronym)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
• IPD Sharing Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
• IPD Sharing Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No