A Study of Recombinant Von Willebrand Factor (rVWF) in Pediatric and Adult Participants With Severe Von Willebrand Disease (VWD)

A Phase 3b, Prospective, Open-Label, Uncontrolled, Multicenter Study on Long-Term Safety and Efficacy of rVWF in Pediatric and Adult Subjects With Severe Von Willebrand Disease (VWD)

The main aim of the study is to check effectiveness of rVWF (vonicog alfa) prophylaxis based on the annualized bleeding rate (ABR) of spontaneous (not related to trauma) bleeding episodes in pediatric and adult participants during the first 12 months on study treatment.

The participants will be treated with rVWF for a maximum of 3 years. Their von Willebrand Disease will be treated according to Investigational product (IP) dosing directions.

Study Overview

• Status: Completed
• Conditions: Von Willebrand Disease (VWD)
• Intervention / Treatment: Biological: rVWF; Biological: rFVIII

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • AKH - Medizinische Universitat Wien
• France
  • Bron, France, 69677
    • Groupement Hospitalier Est- Hôpital Louis Pradel
  • Gironde, France
    • Groupe Hospitalier Pellegrin - Hôpital Pellegrin
  • Le Kremlin-Bicêtre, France, 94270
    • Groupement Hospitalier Sud - Hôpital Bicêtre
  • Nord
    • Lille, Nord, France
      • Hopital Cardiologique - CHU Lille
  • Paris
    • Paris, Paris, France, 75015
      • Hopital Necker - Enfants Malades
• Germany
  • Frankfurt, Germany
    • Klinikum Der Johann Wolfgang Goethe-Universitaet
  • Hanover, Germany
    • Werlhof-Institut GmbH
• Italy
  • Florence, Italy, 50134
    • Azienda Ospedaliera Universitaria Careggi
  • Milan, Italy
    • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Napoli, Italy
    • Azienda Ospedaliera Pediatrica Santobono Pausillipon
  • Roma, Italy
    • Ospedale Pediatrico Bambino Gesù
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Roma, Italy, 00185
    • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
• Netherlands
  • Rotterdam, Netherlands, 3015 CN
    • Erasmus Medisch Centrum
  • Rotterdam, Netherlands, 3015 AA
    • Erasmus Medisch Centrum
• Russia
  • Kemerovo, Russia, 650066
    • SAIH "Kemerovo Regional Clinical Hospital"
  • Kirov, Russia, 610017
    • FSBI of Science "Kirov Scientific and Research Institute of Hematology and Blood Transfusion of FMBA
• Spain
  • Alicante, Spain, 03010
    • Hospital General Universitario de Alicante
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe
• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • Istanbul University Oncology Institute
  • Izmir, Turkey (Türkiye), 35040
    • Ege University Medical Faculty
  • Izmir, Turkey (Türkiye), 35100
    • Ege University Medical Faculty
  • Samsun, Turkey (Türkiye), 55139
    • Ondokuz Mayis Univ. Med. Fac.
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Arkansas Children's Hospital Research Institute
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Health
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida College of Medicine
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Indiana Hemophilia and Thrombosis Center
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
    • Cleveland, Ohio, United States, 44106
      • Rainbow Babies and Children's Hospital
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina (MUSC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

The participant will not be considered eligible for the study without meeting all of the criteria below.

Participants who have completed Study 071301 or Study 071102 (or participants who have completed the surgery arm treatment in Study 071102 and want to continue to receive on-demand (OD) treatment) and are willing to immediately transition into this study, must meet the following 2 criteria to be eligible for this study:

• If female of childbearing potential, has a negative blood/urine pregnancy test at screening and agrees to employ highly effective birth control measures for the duration of the study.
• Participant and/or legally authorized representative is willing and able to comply with the requirements of the protocol.

New participants (Cohort 4) who meet the above 2 and ALL the following additional criteria are eligible for this study:

- Participant has a documented diagnosis of severe von Willebrand disease (VWD) (baseline von Willebrand factor: Ristocetin cofactor (VWF:RCo) <20 International Units per deciliter [IU/dL]) with a history of requiring substitution therapy with von Willebrand factor (vWF) concentrate to control bleeding:

• Type 1 (VWF:RCo <20 IU/dL) or,
• Type 2A (as verified by multimer pattern), Type 2B (as diagnosed by genotype), Type 2M or,
• Type 3 (Von Willebrand factor antigen (VWF:Ag) less than or equal to (<=) 3 IU/dL).

Diagnosis is confirmed by genetic testing and multimer analysis, documented in participant history or at screening.

• Participant has been receiving OD therapy with VWF products for at least 12 months, and prophylactic treatment is recommended by the investigator.
• Participant has greater than or equal to (>=) 3 documented spontaneous bleeds (not including menorrhagia) requiring VWF treatment during the past 12 months.
• Participant has available records that reliably evaluate type, frequency, and treatment of bleeding episodes for at least 12 months preceding enrollment; up to 24 months of retrospective data should be collected if available.
• Participant is >=12 years old at the time of screening and has a body mass index >=15 but <40 kilogram per meter square (kg/m^2).

Exclusion Criteria:

The participant will be excluded from the study if any of the following exclusion criteria are met.

• The participant has been diagnosed with Type 2N VWD, pseudo VWD, or another hereditary or acquired coagulation disorder other than VWD (eg, qualitative and quantitative platelet disorders or elevated prothrombin time (PT)/international normalized ratio [INR] >1.4).
• The participant has a history or presence of a VWF inhibitor at screening.
• The participant has a history or presence of a Factor VIII (FVIII) inhibitor with a titer >=0.4 Bethesda units (BU) (by Nijmegen modified Bethesda assay) or >=0.6 BU (by Bethesda assay).
• The participant has a known hypersensitivity to any of the components of the study drugs, such as mouse or hamster proteins.
• The participant has a medical history of immunological disorders, excluding seasonal allergic rhinitis/conjunctivitis, mild asthma, food allergies, or animal allergies.
• The participant has a medical history of a thromboembolic event.
• The participant is human immunodeficiency virus (HIV) positive with an absolute Helper T cell (CD4) count <200/cubic millimeters (mm^3).
• The participant has been diagnosed with significant liver disease per investigator's medical assessment of the participant's current condition or medical history or as evidenced by, but not limited to any of the following: serum alanine aminotransferase (ALT) greater than 5 times the upper limit of normal; hypoalbuminemia; portal vein hypertension (eg, presence of otherwise unexplained splenomegaly, history of esophageal varices) or liver cirrhosis classified as Child-Pugh class B or C.
• The participant has been diagnosed with renal disease, with a serum creatinine (CR) level >=2.5 milligrams per deciliter (mg/dL).
• The participant has a platelet count <100,000/milliliter (mL) at screening.
• The participant has been treated with an immunomodulatory drug, excluding topical treatment (eg, ointments, nasal sprays), within 30 days prior to signing the informed consent (or assent, if appropriate).
• The participant is pregnant or lactating at the time of enrollment.
• The participant has cervical or uterine conditions causing menorrhagia or metrorrhagia (including infection, dysplasia).
• The participant has participated in another clinical study involving another investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study.
• The participant has a progressive fatal disease and/or life expectancy of less than 15 months.
• For new OD participants, the participant is scheduled for a surgical intervention.
• The participant is identified by the investigator as being unable or unwilling to cooperate with study procedures.
• The participant has a mental condition rendering him/her unable to understand the nature, scope and possible consequences of the study and/or evidence of an uncooperative attitude.
• The participant is member of the study team or in a dependent relationship with one of the study team members which includes close relatives (i.e., children, partner/spouse, siblings and parents) as well as employees.

Delay criteria Only for Cohort 4, if the participant presents with an acute bleeding episodes or acute illness (eg, influenza, flu-like syndrome, allergic rhinitis/conjunctivitis, and non-seasonal asthma) the screening visit will be postponed until the participant has recovered. For all other participants, end of study (EOS) visit for 071102 or 071301 will be completed per protocol and the completed EOS in Study 071102 or 071301 will also serve as the screening visit for this continuation study (SHP677-304).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: On-Demand; Participants will receive recombinant von Willebrand factor (rVWF) (with or without ADVATE).	Biological: rVWF; Recombinant von Willebrand factor; Other Names: Vonvendi; Vonicog alfa; Biological: rFVIII; Recombinant Factor VIII; Other Names: ADVATE; Octocog alfa
Experimental: Prophylaxis; Participants will receive recombinant von Willebrand factor (rVWF).	Biological: rVWF; Recombinant von Willebrand factor; Other Names: Vonvendi; Vonicog alfa; Biological: rFVIII; Recombinant Factor VIII; Other Names: ADVATE; Octocog alfa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spontaneous Annualized Bleeding Rate (sABR)	sABR was derived as [number of treated bleeds] / [duration in years]. Bleeds with unknown causality were considered as spontaneous. Bleeds were categorized based on the investigator assessment of cause. sABR during the first 12 months of prophylactic treatment with rVWF (vonicog alfa) was reported.	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs	An adverse event (AE): any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to medicinal product. TEAE was defined as any AE that started after the first administration of study drug in this continuation study. Serious TEAEs: any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is medically important.	Up to 5.8 years
Number of Participants Based on Severity of TEAEs	An AE is defined as any untoward medical occurrence in a participant administered IP that does not necessarily have a causal relationship with the treatment. TEAE was defined as any AE that started after the first administration of study drug in this continuation study. Severity of TEAEs was determined by following definitions: Mild: No limitation of usual activities; Moderate: Some limitation of usual activities and may required therapeutic intervention; Severe: Inability to carry out usual activities with sequelae, which required therapeutic intervention. Number of participants with TEAEs based on severity of TEAEs were reported.	Up to 5.8 years
Number of Participants Based on Causality of TEAEs	An AE is defined as any untoward medical occurrence in a participant administered IP that does not necessarily have a causal relationship with the treatment. TEAE was defined as any AE that started after the first administration of study drug in this continuation study. A physician/investigator made the assessment of relationship to investigational product for each AE. Number of participants with TEAEs based on causality were reported.	Up to 5.8 years
Number of Participants With Thromboembolic Events	Thromboembolism defined as formation of a clot (thrombus) in a blood vessel that breaks loose, is carried by the blood stream and could plug another vessel. Number of participants with thromboembolic events as TEAEs of special interest were reported.	Up to 5.8 years
Number of Participants With Hypersensitivity Reactions	Hypersensitivity (also called hypersensitivity reaction or intolerance) defined as undesirable reactions produced by the normal immune system, including allergies and autoimmunity. Potential hypersensitivity events were identified by broad search criteria and then medically assessed. Number of participants with hypersensitivity reactions as TEAEs of special interest was calculated.	Up to 5.8 years
Number of Participants Who Developed Neutralizing Antibodies to Von Willebrand Factor (VWF)	Three functional VWF assays for von Willebrand factor collagen binding (VWF:CB), von Willebrand factor: Ristocetin Cofactor (VWF:RCo) and von Willebrand factor VIII B (VWF:FVIIIB) were used to test the presence of neutralizing anti-VWF antibodies. Neutralizing antibodies to VWF:RCo, VWF:CB and VWF:FVIIIB activities were measured by assays based on the Bethesda assay established for quantitative analysis of FVIII inhibitors (Nijmegen modification of the Bethesda assay). Only confirmed neutralizing anti -VWF antibodies were considered inhibitors. Number of participants who developed neutralizing antibodies to rVWF were assessed.	Up to 5.8 years
Number of Participants Who Developed Neutralizing Antibodies to Factor VIII (FVIII)	Three functional VWF assays for von Willebrand factor collagen binding (VWF:CB), von Willebrand factor: Ristocetin Cofactor (VWF:RCo) and von Willebrand factor VIII B (VWF:FVIIIB) were used to test the presence of neutralizing anti-VWF antibodies. Neutralizing antibodies to VWF:RCo, VWF:CB and VWF:FVIIIB activities was measured by assays based on the Bethesda assay established for quantitative analysis of FVIII inhibitors (Nijmegen modification of the Bethesda assay). Only confirmed neutralizing anti -VWF antibodies were considered inhibitors. Number of participants who developed neutralizing antibodies to FVIII were assessed.	Up to 5.8 years
Number of Participants Who Developed Total Binding Antibodies to Von Willebrand Factor (VWF)	The presence of total binding anti-VWF antibodies was determined by an enzyme-linked immunosorbent assay (ELISA) employing polyclonal anti-human Immunoglobulin (Ig) antibodies (IgG, IgM and IgA). Number of participants who developed of total binding antibodies to rVWF were assessed.	Up to 5.8 years
Number of Participants Who Developed Total Binding Antibodies to Factor VIII (FVIII)	Binding antibodies against FVIII were analyzed using a proprietary enzyme immunoassay. Number of participants who developed of total binding antibodies to FVIII were assessed.	Up to 5.8 years
Number of Participants Who Developed Binding Antibodies to Chinese Hamster Ovary (CHO) Proteins	Total Ig antibodies (IgG, IgA, IgM) against CHO protein were analyzed using ELISA. Number of participants who developed binding antibodies to CHO proteins were assessed.	Up to 5.8 years
Number of Participants Who Developed Binding Antibodies to Mouse Immunoglobulin G (IgG)	Detection and quantification of IgG antibodies originating from human plasma that were directed against mouse-IgG (HAMA: human anti- mouse antibodies) were assessed using ELISA (Medac, Hamburg, Germany). Number of participants who developed binding antibodies to Mouse IgG were assessed.	Up to 5.8 years
Number of Participants Who Develop Binding Antibodies to Recombinant Furin (rFurin)	Total Ig antibodies (IgG, IgA, IgM) against human furin were analyzed using ELISA. Number of participants who developed binding antibodies to rFurin were assessed.	Up to 5.8 years
Number of Participants With Clinically Significant Changes in Vital Signs	Vital signs included blood pressure (systolic and diastolic), pulse rate, respiratory rate and body temperature. Number of participants with clinically significant change from baseline in vital signs were assessed.	Up to 5.8 years
Number of Participants With Clinically Significant Changes in Laboratory Parameters	Clinical laboratory parameters included serum chemistry, hematology and urinalysis assessments. Number of participants with clinically significant change from baseline in clinical laboratory parameters were assessed.	Up to 5.8 years
Spontaneous Annualized Bleeding Rate (sABR) Under Prophylactic Treatment	sABR was derived as [number of treated bleeds] / [duration in years]. Bleeds with unknown causality were considered as spontaneous. Bleeds were categorized based on the investigator assessment of cause. sABR during prophylaxis treatment with rVWF (vonicog alfa) while enrolled in the study were reported.	Up to 5.8 years
Number of Participants Categorized Based on Weekly Number of Infusions	Categorized as ≥ 0 to < 1 infusion per week, ≥ 1 to < 2 infusions per week, ≥ 2 to < 3 infusions per week, ≥ 3 infusions per week. The number of participants categorized based on number of infusions per week during prophylactic treatment with rVWF (vonicog alfa) were reported.	Up to 5.8 years
Number of Participants Categorized Based on Spontaneous Annualized Bleeding Rate (sABR)	The sABR was the number of spontaneous bleeds divided by the observation period in years, where an observation period = (date of completion/termination-date of first dose+1)/365.2425. sABR was categorized based on number of BEs as 0, greater than (>) 0 through 2, >2 through 5, >5 during the prophylactic treatment with rVWF (vonicog alfa). Bleeding at multiple locations related to the same injury was counted as single BE. BEs of unknown cause were counted as spontaneous bleeds. Number of participants categorized based on sABR during prophylactic treatment with rVWF (vonicog alfa) were reported.	Up to 5.8 years
Time to First Bleeding Event on Prophylaxis Treatment	Time to event estimates and confidence intervals obtained from Kaplan-Meier analysis. Participants with 0 bleeds during each study period were censored at the date of the last day in that study period.	Up to 5.8 years
Spontaneous Annualized Bleeding Rate (sABR) by Location of Bleeding	sABR was derived as [number of treated bleeds] / [duration in years]. sABR for BEs based on location of bleeding: Skin, Muscle, Mucosal Nasal, Mucosal Oral, Joint, Gastrointestinal (GI), Menstrual/Heavy Menstrual, Venipuncture Site, Soft Tissue, Body Cavity, Hematuria, Central Nervous System (CNS) and Other, while on prophylactic treatment with rVWF (vonicog alfa) were reported.	Up to 5.8 years
Total Number of Infusions During Prophylactic Treatment	Total number of infusions during prophylactic treatment with rVWF (vonicog alfa) were reported.	Up to 5.8 years
Average Number of Infusions Per Week During Prophylactic Treatment	Average number of infusions per week during prophylactic treatment with rVWF (vonicog alfa) were reported.	Up to 5.8 years
Total Weight Adjusted Consumption of Recombinant Von Willebrand Factor (rVWF) (Vonicog Alfa) Per Participant During Prophylactic Treatment	For each participant, the body weight-adjusted dose (IU/kg) was derived as the number of units of rVWF infused (IU) divided by the last available body weight (kilogram [kg]) prior to the infusion. Total weight adjusted consumption of rVWF (vonicog alfa) per participant during prophylactic treatment with rVWF (vonicog alfa) was reported as International Units per kilogram (IU/kg).	Up to 5.8 years
Number of Participants Who Achieved Transfusion-free Maintenance of Hemoglobin Levels	Transfusion free maintenance of hemoglobin levels during prophylactic treatment with rVWF (vonicog alfa) were reported.	Up to 5.8 years
Change From Baseline in Ferritin Levels Over Time	Change from baseline in ferritin levels over time during prophylactic treatment with rVWF (vonicog alfa) were reported. Baseline Ferritin lab assay for rollover participants in cohorts 1, 2 and 3 were not mandatory per protocol at the Screening Visit of this study as the results from End of Study (EOS) visit of parent studies were expected to be utilized for rollover cohorts 1-3. However, many participants in cohort 1 did not have this data collected at EOS Visit of parent study 071301 and no participant in cohorts 2 and 3 had this data collected at EOS Visit of parent studies 071301 and 071102.	Up to 5.8 years
Overall Hemostatic Efficacy Rating	Overall Hemostatic Efficacy Rating at resolution of bleed with respect to treatment of BEs for initial 12 months of study in OD cohorts. Hemostatic efficacy for treatment of BEs was rated on 4-point Likert scale as:excellent=full relief of pain&cessation of objective signs of bleeding after single infusion,no additional infusion is required for control of bleeding&administration of further infusion to maintain hemostasis would not affect scoring;good=definite pain relief&/or improvement in signs of bleeding after single infusion,possibly requires >2 infusions for complete resolution&administration of further infusion to maintain hemostasis would not affect scoring;fair=probable&/or slight relief of pain&slight improvement in signs of bleeding after single infusion,required multiple infusions for complete resolution;none=no improvement of signs/symptoms or conditions worsen.Missing=number of unique BEs without any overall hemostatic efficacy rating at resolution of breakthrough BE.	Initial 12 months of study
Number of Infusions of Vonicog Alfa	Number of infusions of rVWF (vonicog alfa) utilized to treat BEs during OD treatment while enrolled in the study were reported.	Up to 5.8 years
Number of Infusions of ADVATE	Number of infusions of ADVATE (rFVIII, octocog alfa) utilized to treat BEs during OD treatment while enrolled in the study were reported.	Up to 5.8 years
Weight-adjusted Consumption of Vonicog Alfa Per Bleeding Episode	Weight-adjusted consumption (IU/kg) was derived as the total units infused (IU) divided by the last available body weight (kg) prior to the infusion. Weight-adjusted consumption of rVWF (vonicog alfa) per bleeding episode during OD treatment while enrolled in the study were reported.	Up to 5.8 years
Weight-adjusted Consumption of ADVATE Per Bleeding Episode	Weight-adjusted consumption (IU/kg) was derived as the total units infused (IU) divided by the last available body weight (kg) prior to the infusion. Weight-adjusted consumption of ADVATE (rFVIII, octocog alfa) per bleeding episode during OD treatment while enrolled in the study were reported.	Up to 5.8 years

Collaborators and Investigators

• Sponsor: Baxalta now part of Shire
• Collaborators: Takeda Development Center Americas, Inc.
• Investigators: Study Director: Study Director, Takeda

Publications and helpful links

Helpful Links

• To obtain more information on the study, click here/on this link

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): January 30, 2025
• Study Completion (Actual): January 30, 2025

Study Registration Dates

• First Submitted: December 20, 2018
• First Submitted That Met QC Criteria: March 15, 2019
• First Posted (Actual): March 18, 2019

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Hematologic Diseases; Blood Coagulation Disorders; Hemorrhagic Disorders; Blood Platelet Disorders; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hemic and Lymphatic Diseases; von Willebrand Diseases; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Blood Proteins; Blood Coagulation Factors; Protein Precursors; Factor VIII; F8 protein, human
• Other Study ID Numbers: SHP677-304; 2018-003453-16 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; 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