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Efficacy and Safety Study of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir

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ClinicalTrials.gov Identifier: NCT02931539
Recruitment Status : Recruiting
First Posted : October 13, 2016
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Shire

September 29, 2016
October 13, 2016
September 26, 2018
December 29, 2016
May 6, 2019   (Final data collection date for primary outcome measure)
Proportion of Participants who Achieve Confirmed Clearance of Plasma CMV DNA (CMV Viremia Clearance) at Week 8 [ Time Frame: Week 8 ]
Confirmed CMV viremia clearance is defined as plasma CMV DNA concentration less than (<) lower limit of quantification (LLOQ) that is (i.e), <137 International Units per millilitre (IU/mL) when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive postbaseline samples, separated by at least 5 days, regardless of whether either study assigned treatment is discontinued before the end of the stipulated 8 weeks of therapy.
To compare the efficacy of maribavir to investigator-assigned anti-CMV therapy in CMV viremia clearance as measured by plasma CMV DNA concentration, at the end of the study treatment period [ Time Frame: Week 0 to week 8 ]
Complete list of historical versions of study NCT02931539 on ClinicalTrials.gov Archive Site
  • Proportion of Participants who Achieve CMV Viremia Clearance and Tissue-invasive CMV Disease or CMV Syndrome Improvement or Resolution [ Time Frame: Baseline, Week 8, Week 16 ]
    Confirmed CMV viremia clearance is defined as plasma CMV DNA concentration <LLOQ i.e, <137 IU/mL when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive postbaseline samples, separated by at least 5 days. The gold standard for diagnosing CMV tissue invasive disease is the identification of CMV inclusions in the infected cells of the tissues or identification of CMV in biopsy tissue samples. Achievement of CMV viremia clearance and resolution or improvement of tissue-invasive CMV disease or CMV syndrome for participants symptomatic at baseline or achievement of clearance of viremia and no symptoms of tissue invasive CMV disease or CMV syndrome for participants asymptomatic at baseline at the end of Study Week 8, regardless of whether either study-assigned treatment was discontinued before the end of the stipulated 8 weeks of therapy, followed by maintenance of this treatment effect (Follow-up Week 16) will be assessed.
  • Proportion of Participants who Achieve Confirmed Clearance of Plasma CMV DNA (CMV Viremia Clearance) After 8 Weeks of Receiving Study-assigned Treatment [ Time Frame: Week 8 ]
    Confirmed CMV viremia clearance is defined as plasma CMV DNA concentration <LLOQ i.e, <137 IU/mL when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive postbaseline samples, separated by at least 5 days.
  • Proportion of Participants who Achieve CMV Viremia Clearance and CMV infection symptom After 8 Weeks of Receiving Study-assigned Treatment [ Time Frame: Baseline, Week 8, Week 12, Week 16, Week 20 ]
    Confirmed CMV viremia clearance is defined as plasma CMV DNA concentration <LLOQ i.e, <137 IU/mL when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive post baseline samples, separated by at least 5 days. The gold standard for diagnosing CMV tissue invasive disease is the identification of CMV inclusions in the infected cells of the tissues or identification of CMV in biopsy tissue samples. Achievement of CMV viremia clearance and CMV infection symptom for participants symptomatic at baseline or achievement of clearance of viremia and no symptoms of tissue invasive CMV disease or CMV infection symptom for participants asymptomatic at baseline after receiving 8 weeks of study-assigned treatment, followed by maintenance of this treatment effect through study weeks 12, week 16 and week 20 will be assessed.
  • Proportion of Participants who Maintain Confirmed CMV Viremia Clearance and CMV Infection Symptom Control [ Time Frame: Week 8, Week 12 and Week 20 ]
    Proportion of participants who maintain confirmed CMV viremia clearance and CMV infection symptom control, regardless of whether either study-assigned treatment was discontinued before the end of the stipulated 8 weeks of therapy will be assessed.
  • Proportion of Participants With Recurrence of CMV Viremia [ Time Frame: Baseline to Week 20 ]
    Recurrence of CMV viremia is defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance, regardless of whether either study-assigned treatment was discontinued before the end of the stipulated 8 weeks of therapy.
  • Proportion of Participants With Recurrence of CMV Viremia During the First 8 Weeks of the Study [ Time Frame: Baseline to Week 8 ]
    Recurrence of CMV viremia is defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance, regardless of whether either study-assigned treatment was discontinued before the end of the stipulated 8 weeks of therapy.
  • Proportion of Participants With Recurrence of CMV Viremia During 12 weeks of the Follow-up Phase [ Time Frame: Week 8 to Week 20 ]
    Recurrence of CMV viremia is defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance, regardless of whether either study-assigned treatment was discontinued before the end of the stipulated 8 weeks of therapy.
  • Proportion of Participants With Recurrence of CMV Viremia who Completed 8 Weeks of Study-assigned Treatment [ Time Frame: Baseline to Week 20 ]
    Recurrence of CMV viremia is defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance.
  • Proportion of Participants With Recurrence of CMV Viremia During the First 8 Weeks of the Treatment who Completed 8 Weeks of Study-assigned Treatment [ Time Frame: Baseline to Week 8 ]
    Recurrence of CMV viremia is defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance.
  • Proportion of Participants With Recurrence of CMV Viremia During 12 weeks of the Follow-up Phase who Completed 8 Weeks of Study-assigned Treatment [ Time Frame: Week 8 to Week 20 ]
    Recurrence of CMV viremia is defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance.
  • Proportion of Participants With Recurrence of CMV Viremia While on Study-assigned Treatment [ Time Frame: Baseline up to termination of study treatment (up to 8 weeks) ]
    Recurrence of CMV viremia is defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance.
  • Proportion of Participants With Recurrence of CMV Viremia in the Period From the Termination of Study Treatment to the End of the Study [ Time Frame: Termination of Study Treatment to the End of the Study (12 weeks) ]
    Recurrence of CMV viremia is defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance.
  • Proportion of Participants who Develop Maribavir CMV Resistance [ Time Frame: Baseline to Week 20 ]
    Proportion of participants who develop resistance to maribavir will be assessed.
  • Number of Participants With All-cause Mortality [ Time Frame: Baseline to week 20 ]
    Mortality will be assessed by the number of participants who died between week 0 to week 20.
  • Proportion of Participants who Achieve Confirmed Clearance of Plasma CMV DNA (CMV Viremia Clearance) at Week 8 After Starting Maribavir Rescue Treatment [ Time Frame: From start of maribavir rescue treatment through 8 weeks ]
    Confirmed CMV viremia clearance is defined as plasma CMV DNA concentration <LLOQ i.e, <137 IU/mL when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive postbaseline samples, separated by at least 5 days.
  • Proportion of Participants who Achieve CMV Viremia Clearance and Tissue-invasive Disease or CMV Syndrome Improvement or Resolution After Starting Maribavir Rescue Treatment [ Time Frame: From start of maribavir rescue treatment through 16 weeks ]
    Confirmed CMV viremia clearance is defined as plasma CMV DNA concentration <LLOQ i.e, <137 IU/mL when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive postbaseline samples, separated by at least 5 days. The gold standard for diagnosing CMV tissue invasive disease is the identification of CMV inclusions in the infected cells of the tissues or identification of CMV in biopsy tissue samples. Achievement of CMV viremia clearance and resolution or improvement of tissue-invasive CMV disease for participants symptomatic at baseline or achievement of clearance of viremia and no symptoms of tissue invasive CMV disease for participants asymptomatic at baseline after receiving maribavir rescue treatment, followed by maintenance of this treatment effect through study Week 16 will be assessed.
  • Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Baseline to Week 20 ]
    An adverse event (AE) is any untoward medical occurrence in a participant who will receive study drug without regard to possibility of causal relationship. TEAEs are defined as AEs that has a start date on or after the first dose of study treatment or that has a start date before the date of first dose of study treatment, but increases in severity after the first dose of study treatment.
  • Predose Concentration (Cmin) of Maribavir [ Time Frame: Predose at Week 1, 4 and 8 ]
    Cmin of Maribavir will be assessed.
  • Area Under the Concentration Time Curve Over the 12-hour Dosing Interval at Steady State (AUC0-tau) [ Time Frame: Week 1: Pre-morning dose and 1, 2, 3, 4, 6, 8 and 12 hours post morning dose Week 4: Pre-morning dose Week 8: Pre-morning dose and 2-4 hour post morning dose ]
    AUC0-tau of Maribavir will be assessed.
  • Maximum Plasma Concentration (Cmax) of Maribavir [ Time Frame: Week 1: Pre-morning dose and 1, 2, 3, 4, 6, 8 and 12 hours post morning dose Week 4: Pre-morning dose Week 8: Pre-morning dose and 2-4 hour post morning dose ]
    Cmax of Maribavir will be assessed.
  • Time When Maximum Concentration is Observed (Tmax) of Maribavir [ Time Frame: Week 1: Pre-morning dose and 1, 2, 3, 4, 6, 8 and 12 hours post morning dose Week 4: Pre-morning dose Week 8: Pre-morning dose and 2-4 hour post morning dose ]
    Tmax of Maribavir will be assessed.
  • Apparent Oral Clearance (CL/F) of Maribavir [ Time Frame: Week 1: Pre-morning dose and 1, 2, 3, 4, 6, 8 and 12 hours post morning dose Week 4: Pre-morning dose Week 8: Pre-morning dose and 2-4 hour post morning dose ]
    CL/F of Maribavir will be assessed.
  • Apparent Volume of Distribution (Vz/F) of Maribavir [ Time Frame: Week 1: Pre-morning dose and 1, 2, 3, 4, 6, 8 and 12 hours post morning dose Week 4: Pre-morning dose Week 8: Pre-morning dose and 2-4 hour post morning dose ]
    Vz/F of Maribavir will be assessed.
  • CMV viremia clearance, resolution/improvement of tissue invasive CMV disease if present at baseline and no new onset of tissue invasive CMV disease in patients asymptomatic at baseline, at the end of the study treatment and the follow up [ Time Frame: Week 0 to week 8 and then to 16 ]
  • Assess the maintenance of CMV viremia clearance reached at the end of study treatment, in study treatment arms [ Time Frame: Week 8 to week 12, 16 or 20 ]
  • Assess the maintenance of first achieved viremia clearance, irrespective of the duration of the study treatment [ Time Frame: Week 0 to week 8 ]
  • Maintenance of CMV viremia clearance and resolution/improvement of tissue invasive CMV disease if present at baseline, and no new onset of tissue invasive CMV disease in patients asymptomatic at baseline, off treatment [ Time Frame: Week 8 to week 12 or 20 ]
  • Participant incidence of recurrence of CMV viremia in the two study treatment arms while on study treatment (on treatment) [ Time Frame: Week 0 to week 8 ]
  • Participant incidence of recurrence of CMV viremia in the two study treatment arms in the period after the end of study treatment (off treatment) [ Time Frame: Week 8 to Week 20 ]
  • Profile of Mutations in the CMV Genes Conferring Resistance to Maribavir [ Time Frame: Week 0 to week 20 ]
  • Participant all-cause mortality [ Time Frame: Week 0 to week 20 ]
  • Assess the Efficacy of Maribavir Administered as the Rescue Treatment on CMV Viremia Clearance as Measured by Plasma CMV DNA Concentration, at the End of the Study Treatment Period [ Time Frame: Throughout 8 weeks from the entry into maribavir rescue arm ]
  • CMV Viremia Clearance, Resolution/Improvement of Tissue Invasive CMV Disease if Present at Baseline and no New Onset of Disease in Patients Asymptomatic at Baseline, at the End of the Study Treatment and the Follow up in Maribavir Rescue Arm [ Time Frame: Throughout 8 weeks from the entry into maribavir rescue arm to 8 weeks of follow-up ]
  • Participant safety and tolerability of maribavir measured by treatment-emergent adverse events (TEAEs) and treatment-emergent SAEs, overall study AEs and overall study SAEs [ Time Frame: Week 0 to week 20 ]
  • Pharmacokinetics (PK) of Maribavir Based on Sparse Sampling as Measured by Area Under The Curve (AUC) [ Time Frame: Week 1 to week 8 ]
  • Participant change from baseline in vital signs [ Time Frame: Baseline to week 20 ]
  • Participant change from baseline in clinical laboratory tests [ Time Frame: Baseline to week 20 ]
  • Participant summary of abnormal findings from physical examination [ Time Frame: Baseline to week 20 ]
  • Participant change from baseline in ECG assessment [ Time Frame: Baseline to week 20 ]
  • Change from baseline in the number of participants that require treatment with hemopoietic growth factors [ Time Frame: Baseline to week 20 ]
  • Change from baseline in the number of participants that require treatment with blood or blood products [ Time Frame: Baseline to week 20 ]
  • Change from baseline in the number of participants that require treatment with invasive bacterial and fungal infections [ Time Frame: Baseline to week 20 ]
Not Provided
Not Provided
 
Efficacy and Safety Study of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir
A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir
The purpose of this study is to compare the efficacy of maribavir to investigator-assigned anti-Cytomegalovirus (CMV) therapy in CMV viremia clearance in transplant recipients who are refractory or resistant to prior anti-CMV treatment.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cytomegalovirus (CMV)
  • Drug: Maribavir
    Maribavir 400 milligrams (mg) (2x200 mg tablets) will be administered twice daily for 8 weeks.
    Other Name: SHP620
  • Drug: Ganciclovir
    Ganciclovir as per the investigator's prescribed dosing regimen will be administered for 8 weeks.
  • Drug: Valganciclovir
    Valganciclovir as per the investigator's prescribed dosing regimen will be administered for 8 weeks.
  • Drug: Foscarnet
    Foscarnet as per the investigator's prescribed dosing regimen will be administered for 8 weeks.
  • Drug: Cidofovir
    Cidofovir as per the investigator's prescribed dosing regimen will be administered for 8 weeks.
  • Experimental: Maribavir Treatment
    Participants will receive 400 milligrams (mg) (2x200 mg tablets) maribavir twice daily orally (doses separated by a minimum of 8 hours) for 8 weeks.
    Intervention: Drug: Maribavir
  • Active Comparator: Investigator-Assigned Treatment
    Participants will receive anti-CMV agent best suited to treat the respective participant as per the investigator's prescribed dosing regimen for 8 weeks. Agents of choice include: ganciclovir, valganciclovir, foscarnet, or cidofovir.
    Interventions:
    • Drug: Ganciclovir
    • Drug: Valganciclovir
    • Drug: Foscarnet
    • Drug: Cidofovir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
351
Same as current
May 6, 2019
May 6, 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. The participant must be able to provide written, personally signed, and dated informed consent to participate in the study before completing any study-related procedures. As applicable, a parent/both parents or legally authorized representative (LAR) must provide signature of informed consent and there must be documentation of assent by the participant before completing any study-related procedures.
  2. The participant must be a recipient of hematopoietic stem cell or solid organ transplant.
  3. The participant must have a documented CMV infection in whole blood or plasma, with a screening value of greater than or equal to (>=) 2730 international units per milliliter (IU/mL) in whole blood or >= 910 IU/mL in plasma in 2 consecutive assessments, separated by at least 1 day, as determined by local or central speciality laboratory quantitative polymerase chain reaction (qPCR) or comparable quantitative CMV DNA results. Both samples should be taken within 14 days prior to randomization with second sample obtained within 5 days prior to randomization. The same laboratory and same sample type (whole blood or plasma) must be used for these assessments.
  4. The participant must have a current CMV infection that is refractory to the most recently administered of the four anti-CMV treatment agents. Refractory is defined as documented failure to achieve greater than (>) 1 log10 (common logarithm to base 10) decrease in CMV DNA level in whole blood or plasma after a 14 day or longer treatment period with intravenous (IV) ganciclovir/oral valganciclovir, IV foscarnet, or IV cidofovir.

    a. Participants with documentation of 1 or more CMV genetic mutations associated with resistance to ganciclovir/valganciclovir, foscarnet, and/or cidofovir must also meet the definition of refractory CMV infection.

  5. The Investigator must be willing to treat the participant with at least one of the available anti-CMV drugs (ganciclovir, valganciclovir, foscarnet, or cidofovir). Note: Combination therapy with foscarnet and cidofovir is not permitted in the investigator-assigned anti-CMV treatment (IAT) arm due to the potential for serious nephrotoxicity.
  6. The participant must be >= 12 years of age at the time of consent
  7. The participant must weigh >= 35 kilogram (kg).
  8. The participant must have all of the following results as part of screening laboratory assessments (results from either the central laboratory or a local laboratory can be used for qualification):

    1. Absolute neutrophil count (ANC) >= 1000/ millimeter cube (mm^3) (1.0 x 109^9/liter [L])
    2. Platelet count >= 25,000/mm^3 [25 x 10^9/L],
    3. Hemoglobin >= 8 gram per deciliter (g/dL).
    4. Estimated glomerular filtration rate (eGFR) > 30 (milliliter per minute (mL/min) /1.73 square meter (m^2) as assessed by Modification of Diet in Renal Disease (MDRD) formula for participants >= 18 years of age or Schwartz formula for participants less than (<) 18 years of age.
  9. The participant must have a negative serum beta-human chorionic gonadotropin (beta-HCG) pregnancy test at screening, if a female of child bearing potential. Additional urine pregnancy tests may be done per institutional requirements. Sexually active females of child bearing potential must agree to comply with any applicable contraceptive requirements of the protocol. If male, must agree to use an acceptable method of birth control, as defined in the protocol, during the study treatment administration period and for 90 days afterward if treated with maribavir, ganciclovir, valganciclovir, or cidofovir and for 180 days afterward if treated with foscarnet.
  10. The participant must be able to swallow tablets, or receive tablets crushed and/or dispensed in water via nasogastric or orogastric tube.
  11. The participant must be willing and have an understanding and ability to fully comply with study procedures and restrictions defined in the protocol.
  12. The participant must be willing to provide necessary samples (example [e.g,] biopsy) for the diagnosis of tissue invasive CMV disease at baseline as determined by the Investigator.
  13. The participant must have a life expectancy of >= 8 weeks.

Exclusion Criteria:

  1. Have a current CMV infection that is considered refractory or resistant due to inadequate adherence to prior anti-CMV treatment, to the best knowledge of the Investigator.
  2. Require ganciclovir, valganciclovir, foscarnet, or cidofovir administration for conditions other than CMV when study treatment is initiated (example: herpes simplex virus (HSV) coinfection requiring use of any of these agents after the randomization) or would need a coadministration with maribavir for CMV infection. NOTE: A participant who is not continuing with the same anti-CMV drug(s) (ganciclovir, valganciclovir or foscarnet) for the study treatment (if randomized to the investigator assigned anti-CMV treatment arm), must discontinue their use before the first dose of study drug. If participant is currently being treated with cidofovir and is assigned another anti-CMV therapy by the investigator, the participant must discontinue its use at least 14 days prior to randomization at Visit 2/Day 0 and the first dose of study treatment.
  3. Be receiving leflunomide, letermovir, or artesunate when study treatment is initiated. NOTE: Participants who may be receiving leflunomide or letermovir must discontinue the use at least 14 days prior to randomization at Visit 2/Day 0 and the first dose of study treatment. Participants receiving artesunate must discontinue the use prior to the first dose of study treatment.
  4. Have severe vomiting, diarrhea, or other severe gastrointestinal illness within 24 hours prior to the first dose of study treatment that would preclude administration of oral/enteral medication.
  5. Have known hypersensitivity to the active substance or to an excipient for a study treatment.
  6. Have tissue invasive CMV disease with central nervous system involvement including the retina (example, CMV retinitis).
  7. Have serum aspartate aminotransferase (AST) > 5 times upper limit of normal (ULN) at screening, or serum alanine aminotransferase (ALT) > 5 times ULN at screening, or total bilirubin >= 3.0 x ULN at screening (except for documented Gilbert's syndrome), by local or central lab. Participants with biopsy confirmed CMV hepatitis will not be excluded from study participation despite AST or ALT > 5 times ULN at screening.
  8. Have known (previously documented) positive results for human immunodeficiency virus (HIV).
  9. Require mechanical ventilation or vasopressors for hemodynamic support at the time of enrollment.
  10. Be female and pregnant or breast feeding.
  11. Have previously received maribavir.
  12. Have received any investigational agent with known anti-CMV activity within 30 days before initiation of study treatment or investigational CMV vaccine at any time.
  13. Have received any unapproved agent or device within 30 days before initiation of study treatment.
  14. Have active malignancy with the exception of nonmelanoma skin cancer. Participants who have had a hematopoietic stem cell transplant (HSCT) and who experience relapse or progression of the malignancy as per investigator's opinion are not to be enrolled.
  15. Be undergoing treatment for acute or chronic hepatitis C.
  16. Have any clinically significant medical or surgical condition that, in the investigator's opinion, could interfere with the interpretation of study results, contraindicate the administration of the assigned study treatment, or compromise the safety or well-being of the participant.
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Older Adult)
No
Contact: Shire Contact 866-842-5335 ClinicalTransparency@shire.com
Australia,   Austria,   Belgium,   Canada,   Croatia,   France,   Germany,   Italy,   Singapore,   Spain,   United Kingdom,   United States
 
 
NCT02931539
SHP620-303
2015-004725-13 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Shire
Shire
Not Provided
Study Director: Study Director Shire
Shire
September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP