TerminatedNCT03921294Updated Apr 11, 2024Results posted

HemLibra Prophylaxis in Patients With Hemophilic Pseudotumor

A Phase 4 interventional study of Emicizumab in Haemophilic Pseudotumour, sponsored by Indiana Hemophilia &Thrombosis Center, Inc.. Terminated at 1 site in United States. Per ClinicalTrials.gov, last updated 2024-04-11.

Sponsored by Indiana Hemophilia &Thrombosis Center, Inc. · Phase 4, Interventional, and Treatment

Why this study was terminated

Global COVID-19 pandemic prevented further study visits or enrollment.

Phase: Phase 4
Study type: Interventional
Enrollment: 1
Allocation: Not applicable
Sex: All

Study summary

This is a single arm, phase 4, prospective, open-label, United States single-center study to assess the hemostatic efficacy and safety of Hemlibra (emicizumab) for hemostatic control of hemophilia A patients (baseline FVIII level \<40%) with and without inhibitors with hemophilic pseudotumors; secondary outcomes will assess changes in quality of life and activity level in treated patients.

Read the detailed description

This is a single arm, phase 4, prospective, open-label, United States single-center study to assess the hemostatic efficacy and safety of Hemlibra (emicizumab) for hemostatic control of hemophilia A patients, (baseline FVIII level \<40%), children and adults, with and without inhibitors with hemophilic pseudotumors; secondary outcomes will assess changes in quality of life and activity level in treated patients.

Hemlibra (emicizumab) will be administered as primary weekly prophylaxis after the enrollment/screening visit is complete (approximately 7-10 days after screening, if laboratory results are available and eligibility is confirmed). If an activity monitoring device is typically utilized by the patient (eg, a Fitbit) then permission will be requested from the patient at screening to access the data for 1 month prior to screening as a baseline comparator for post-treatment activity. The use of an activity-monitoring device is not required by the study.

The enrollment period is 2 years and the study will last a maximum of 4 years; subjects will receive study medication (Hemlibra, emicizumab) for a minimum of 2 years and a maximum of 4 years based upon time of enrollment. Hemlibra (emicizumab) will be administered using the FDA-approved once-weekly dosing regimen for loading dose and prophylactic dose. Breakthrough bleeding events will be recorded and treated with locally available FVIII (eg, pdFVIII or rFVIII) in non-inhibitor subjects and inhibitor subjects with low titer inhibitors (titer\<5 BU). The lowest dose of FVIII expected to achieve hemostasis will be utilized for treatment of breakthrough bleeding events in non-inhibitor and low-titer inhibitor patients. Subjects with high-titer inhibitors (titer ≥5 BU) and those with low titer inhibitors who do not respond to FVIII will be required to utilize rFVIIa as first line therapy; aPCC (\<100 U/kg/day for preferably no more than 1 day) may only be used upon approval of the Study Investigator and under the supervision of a physician.

The proposed study is seeking to address the following knowledge gaps:

Does weekly prophylactic Hemlibra (emicizumab) reduce the rate of bleeding events in subjects with hemophilia A and pseudotumor, including the rate of hospitalization, anemia and transfusion? Does weekly prophylactic Hemlibra (emicizumab) control the progression of hemophilic pseudotumor? Does weekly prophylactic Hemlibra (emicizumab) result in an increase in QoL and activity level?

Conditions studied

Haemophilic Pseudotumour

In context

Lead sponsor

Indiana Hemophilia &Thrombosis Center, Inc. is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Signed informed consent form from the subject, parent or guardian
Diagnosis of congenital hemophilia A (baseline FVIII level \<40%) with or without FVIII inhibitor, either high or low responding, regardless of titer
Diagnosis of a hemophilic pseudotumor confirmed by radiologic assessment such as CT or MRI
Any weight or BMI
Medical documentation of prophylactic or episodic treatment (FVIII or bypassing agent) and the number of bleeding episodes for at least 16 weeks, and up to 6 months if available, prior to entry into the study
Medical documentation of any need for PRBC transfusion or hospitalization for 6 months prior to entry into the study
Subjects with a history of an inhibitor should provide documentation of the inhibitor history including date of initial diagnosis of inhibitor, peak titer, and agent utilized for hemostatic control
Subjects with high titer inhibitors or those with low titer inhibitors who do not respond to FVIII must be willing to use rFVIIa as first line therapy for the treatment of breakthrough bleeding events
Medical documentation of ITI therapy for subjects with a history of a FVIII inhibitor and ITI, including current FVIII inhibitor titer
Willingness to discontinue any current prophylactic hemostatic regimen (FVIII or bypassing agent) and/or FVIII ITI therapy for the duration of the study
- Subjects receiving FVIII prophylaxis must be willing to discontinue their FVIII prophylactic regimen immediately prior to their second loading dose of Hemlibra (emicizumab)
- Subjects receiving bypassing agent prophylaxis must be willing to discontinue their prophylactic regimen at least 24 hours prior to their first loading dose of Hemlibra (emicizumab)
- Subjects receiving FVIII ITI therapy must be willing to discontinue ITI immediately prior to their first loading dose of Hemlibra (emicizumab)
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including the health-related questionnaires, activity tracking, and bleed diaries, using systems provided during the study
Adequate hepatic function, defined as total bilirubin ≤1.5 × age-adapted upper limit of normal (ULN) (excluding Gilbert's syndrome) and both AST and ALT ≤3 × age-adapted ULN at the time of screening, and no clinical signs or known laboratory/radiographic evidence consistent with cirrhosis
Subjects must be willing to be vaccinated against HAV and HBV if not previously vaccinated, exposed or immune to HAV or HBV*
Adequate hematologic function, defined as a platelet count ≥100,000/μL and a PT≤1.5 times the ULN at the time of screening
Adequate renal function, defined as serum creatinine ≤2.5 × age-adapted ULN and creatinine clearance ≥30 mL/min by Cockcroft-Gault formula
For women with hemophilia of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods that result in a failure rate of \<1% per year during the treatment period and for at least 5 elimination half-lives (24 weeks) after the last dose of study drug

Exclusion criteria

Exclusion Criteria:

Inherited or acquired bleeding disorder other than congenital hemophilia A
Lack of a documented diagnosis of hemophilic pseudotumor
Patients who are at high risk for TMA (eg, have a previous medical or family history of TMA), in the Study Investigator's judgment
History of illicit drug or alcohol abuse within 48 weeks prior to screening, in the Study Investigator's judgment
Previous (within the last 12 months) or current treatment for thromboembolic disease (with the exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing) or signs of thromboembolic disease
Other conditions (eg, certain autoimmune diseases) that may currently increase the risk of bleeding or thrombosis
History of clinically significant hypersensitivity associated with monoclonal antibody therapies or components of the Emicizumab injection
Planned surgery (excluding minor procedures such as tooth extraction or incision and drainage) during the study
Known HIV infection with CD4 counts \<200 cells/μL. HIV infection with CD4 counts ≥200 cells/μL permitted
Use of systemic immunomodulators (eg, interferon) at enrollment or planned use during the study, with the exception of anti-retroviral therapy
Concomitant disease, condition, significant abnormality on screening evaluations or laboratory tests, or treatment that could interfere with the conduct of the study, or that would, in the opinion of the Study Investigator, pose an additional unacceptable risk in administering study drug to the patient
Receipt of any of the following:
- Hemlibra (emicizumab) in a prior investigational study
- An investigational drug to treat or reduce the risk of hemophilic bleeds within 5 half-lives of last drug administration
- A non-hemophilia-related investigational drug within last 30 days or 5 half-lives, whichever is shorter
- Any other investigational drug currently being administered or planned to be administered
Inability to comply with the study protocol in the opinion of the Study Investigator
Pregnancy or lactation or intention to become pregnant during the study
Women with a positive serum pregnancy test result within 10 days prior to initiation of study drug

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 1 participant (actual)

Study arms

Experimental
Single Arm
Patients with hemophilic pseudotumor will be treated with prophylactic emicizumab and assessed for improvement.
Drug: Emicizumab

Interventions

DrugEmicizumab
bispecific monoclonal antibody binding to activated Factor IX and Factor X
Also known as: HemLibra

What researchers measure

Primary outcomes

Hemostatic Efficacy of Prophylactic Weekly Injections of Hemlibra (Emicizumab) Based on Hemoglobin
Maintenance or increase of hemoglobin (g/dl) from participants' baseline level based on serial blood tests.
Time frame: Every 6 months, for the 2 years and 10 months of the patient's study participation duration.
Hemostatic Efficacy of Prophylactic Weekly Injections of Hemlibra (Emicizumab) Based on Participants' Need for Blood Transfusions or Lack of
Whether or not the patient requires blood transfusions (units of RBCs) due to blood loss secondary to lack of hemostatic efficacy during the duration of study treatment duration.
Time frame: Every 6 months, for the 2 years and 10 months of the patient's study participation duration.

Secondary outcomes

Breakthrough Bleeds
Number of breakthrough bleeding events that require hemostatic therapy in addition to Hemlibra prophylaxis
Time frame: Every 6 months, for the 2 years and 10 months of the patient's study participation duration.
Pseudotumor Status
Radiologic evaluation (CT and/or MRI) to evaluate control of progression, stabilization or regression per change in size (measured in cm) of the pseudotumor
Time frame: Every 12 months, for the 2 years and 10 months of the patient's study participation duration.
Patient Quality of Life Based on Haem-A-QOL
The subjective change in quality of life and activity with Hemlibra (emicizumab) prophylaxis will be evaluated during the study. QoL and activity will be assessed using Haem-A-QoL and EQ-5D-5L. Changes in these measures will be determined by changes from the baseline scores compared to follow-up scores.
Time frame: Every 12 months, for the 2 years and 10 months of the patient's study participation duration.
Patient Quality of Life Based on EQ-5D-5L
The subjective change in quality of life and activity with Hemlibra (emicizumab) prophylaxis will be evaluated during the study. QoL and activity will be assessed using Haem-A-QoL and EQ-5D-5L. Changes in these measures will be determined by changes from the baseline scores compared to follow-up scores.
Time frame: Every 12 months, for the 2 years and 10 months of the patient's study participation duration.
Adverse Events
Number of adverse events while on HemLibra (emicizumab) prophylaxis.
Time frame: Every 3 months, for the 2 years and 10 months of the patient's study participation duration.
Serious Adverse Events
Number of SAEs while on HemLibra (emicizumab) prophylaxis
Time frame: Every 3 months, for the 2 years and 10 months of the patient's study participation duration.
Number of Participants With Adverse Events
Number of participants with adverse events while on HemLibra (emicizumab) prophylaxis
Time frame: Every 3 months, for the 2 years and 10 months of the patient's study participation duration.
Anti-Drug Antibodies (ADA)
Development of emicizumab anti-drug antibodies using the ADA assay
Time frame: Every 12 months, for the 2 years and 10 months of the patient's study participation duration.
ADA and Activated Partial Thromboplastin Time (APTT)
If the patient develops an ADA: the ADA's effect on the patient's APTT
Time frame: Every 12 months, for the 2 years and 10 months of the patient's study participation duration.
ADA and Factor VIII (FVIII)
If the patient develops an ADA: the ADA's effecton the patient's FVIII assay
Time frame: Every 12 months, for the 2 years and 10 months of the patient's study participation duration.
Planned or Unplanned Surgery
If the patient requires surgery: Whether the procedure(s) was/were planned versus unplanned
Time frame: Every 6 months, for the 2 years and 10 months of the patient's study participation duration.
Hemostatic Agents in Surgery
If the patient requires surgery: Whether hemostatic agents in addition to Hemlibra were required to achieve or maintain hemostasis
Time frame: Every 6 months, for the 2 years and 10 months of the patient's study participation duration.
Blood Loss in Surgery
If the patient requires surgery: Whether blood loss exceeded the estimated/predicted blood loss relative to a patient without hemophilia
Time frame: Every 6 months, for the 2 years and 10 months of the patient's study participation duration.

Results

Posted Mar 20, 2024

Participant flow

Participant flow — Overall Study
Milestone	Emicizumab (Single Arm)
Started	1
Enrolled	1
Completed treatment	1
Completed	1
Not completed	0

Outcome measures

PrimaryHemostatic Efficacy of Prophylactic Weekly Injections of Hemlibra (Emicizumab) Based on Hemoglobin

Maintenance or increase of hemoglobin (g/dl) from participants' baseline level based on serial blood tests.

Time frame:: Every 6 months, for the 2 years and 10 months of the patient's study participation duration.
Reported as:: Mean · gm/dL

Hemostatic Efficacy of Prophylactic Weekly Injections of Hemlibra (Emicizumab) Based on Hemoglobin
gm/dL	Single Arm
Hemostatic Efficacy of Prophylactic Weekly Injections of Hemlibra (Emicizumab) Based on Hemoglobin	9.5 (8 to 11)

PrimaryHemostatic Efficacy of Prophylactic Weekly Injections of Hemlibra (Emicizumab) Based on Participants' Need for Blood Transfusions or Lack of

Whether or not the patient requires blood transfusions (units of RBCs) due to blood loss secondary to lack of hemostatic efficacy during the duration of study treatment duration.

Time frame:: Every 6 months, for the 2 years and 10 months of the patient's study participation duration.
Reported as:: Count of participants · Participants

Hemostatic Efficacy of Prophylactic Weekly Injections of Hemlibra (Emicizumab) Based on Participants' Need for Blood Transfusions or Lack of
Participants	Emicizumab (Single Arm)
Hemostatic Efficacy of Prophylactic Weekly Injections of Hemlibra (Emicizumab) Based on Participants' Need for Blood Transfusions or Lack of	0

SecondaryBreakthrough Bleeds

Number of breakthrough bleeding events that require hemostatic therapy in addition to Hemlibra prophylaxis

Time frame:: Every 6 months, for the 2 years and 10 months of the patient's study participation duration.
Reported as:: Number · breakthrough bleeding events

Breakthrough Bleeds
breakthrough bleeding events	Single Arm
Breakthrough Bleeds	14

SecondaryPseudotumor Status

Radiologic evaluation (CT and/or MRI) to evaluate control of progression, stabilization or regression per change in size (measured in cm) of the pseudotumor

Time frame:: Every 12 months, for the 2 years and 10 months of the patient's study participation duration.

No measurements were reported for this outcome.

SecondaryPatient Quality of Life Based on Haem-A-QOL

The subjective change in quality of life and activity with Hemlibra (emicizumab) prophylaxis will be evaluated during the study. QoL and activity will be assessed using Haem-A-QoL and EQ-5D-5L. Changes in these measures will be determined by changes from the baseline scores compared to follow-up scores.

Time frame:: Every 12 months, for the 2 years and 10 months of the patient's study participation duration.

No measurements were reported for this outcome.

SecondaryPatient Quality of Life Based on EQ-5D-5L

Time frame:: Every 12 months, for the 2 years and 10 months of the patient's study participation duration.

No measurements were reported for this outcome.

SecondaryAdverse Events

Number of adverse events while on HemLibra (emicizumab) prophylaxis.

Time frame:: Every 3 months, for the 2 years and 10 months of the patient's study participation duration.
Reported as:: Number · adverse events

Adverse Events
adverse events	Single Arm
Adverse Events	3

SecondarySerious Adverse Events

Number of SAEs while on HemLibra (emicizumab) prophylaxis

Time frame:: Every 3 months, for the 2 years and 10 months of the patient's study participation duration.
Reported as:: Number · serious adverse events

Serious Adverse Events
serious adverse events	Single Arm
Serious Adverse Events	0

SecondaryNumber of Participants With Adverse Events

Number of participants with adverse events while on HemLibra (emicizumab) prophylaxis

Time frame:: Every 3 months, for the 2 years and 10 months of the patient's study participation duration.
Reported as:: Number · participants

Number of Participants With Adverse Events
participants	Single Arm
Number of Participants With Adverse Events	1

SecondaryAnti-Drug Antibodies (ADA)

Development of emicizumab anti-drug antibodies using the ADA assay

Time frame:: Every 12 months, for the 2 years and 10 months of the patient's study participation duration.
Reported as:: Number · participants

Anti-Drug Antibodies (ADA)
participants	Single Arm
Anti-Drug Antibodies (ADA)	0

SecondaryADA and Activated Partial Thromboplastin Time (APTT)

If the patient develops an ADA: the ADA's effect on the patient's APTT

Time frame:: Every 12 months, for the 2 years and 10 months of the patient's study participation duration.

No measurements were reported for this outcome.

SecondaryADA and Factor VIII (FVIII)

If the patient develops an ADA: the ADA's effecton the patient's FVIII assay

Time frame:: Every 12 months, for the 2 years and 10 months of the patient's study participation duration.

No measurements were reported for this outcome.

SecondaryPlanned or Unplanned Surgery

If the patient requires surgery: Whether the procedure(s) was/were planned versus unplanned

Time frame:: Every 6 months, for the 2 years and 10 months of the patient's study participation duration.

No measurements were reported for this outcome.

SecondaryHemostatic Agents in Surgery

If the patient requires surgery: Whether hemostatic agents in addition to Hemlibra were required to achieve or maintain hemostasis

Time frame:: Every 6 months, for the 2 years and 10 months of the patient's study participation duration.

No measurements were reported for this outcome.

SecondaryBlood Loss in Surgery

If the patient requires surgery: Whether blood loss exceeded the estimated/predicted blood loss relative to a patient without hemophilia

Time frame:: Every 6 months, for the 2 years and 10 months of the patient's study participation duration.

No measurements were reported for this outcome.

Adverse events

Collected over Every 3 months, for the 2 years and 10 months of the patient's study participation duration.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Single Arm	0/1 (0%)	0/1 (0%)	1/1 (100%)

Most frequent other events

Most frequent other events
Event	Single Arm
Upper respiratory infectionGeneral disorders	1/1
Fall with injurtyMusculoskeletal and connective tissue disorders	1/1
Malaria infectionInfections and infestations	1/1

Baseline characteristics

Patients with Factor VIII deficiency and hemophilia pseudotumor.

Age, Categorical
Age, Categorical(Participants)	Baseline Characteristics
<=18 years	0
Between 18 and 65 years	1
>=65 years	0

Age, Continuous
Age, Continuous(years)	Baseline Characteristics
Mean	31 (31 to 31)

Sex: Female, Male
Sex: Female, Male(Participants)	Baseline Characteristics
Female	0
Male	1

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Baseline Characteristics
Hispanic or Latino	0
Not Hispanic or Latino	1
Unknown or Not Reported	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Baseline Characteristics
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	1
White	0
More than one race	0
Unknown or Not Reported	0

Region of Enrollment
Region of Enrollment(participants)	Baseline Characteristics
United States	1

Study locations

1 site

Indiana Hemophila @Thrombosis Center
Indianapolis, Indiana 46260, United States

References and documents

Publications

Ahlberg AK. On the natural history of hemophilic pseudotumor. J Bone Joint Surg Am. 1975 Dec;57(8):1133-6. PubMed 1202003 ↗
Blanchette VS, Key NS, Ljung LR, Manco-Johnson MJ, van den Berg HM, Srivastava A; Subcommittee on Factor VIII, Factor IX and Rare Coagulation Disorders of the Scientific and Standardization Committee of the International Society on Thrombosis and Hemostasis. Definitions in hemophilia: communication from the SSC of the ISTH. J Thromb Haemost. 2014 Nov;12(11):1935-9. doi: 10.1111/jth.12672. Epub 2014 Sep 3. No abstract available. PubMed 25059285 ↗
Franchini M, Mannucci PM. Hemophilia A in the third millennium. Blood Rev. 2013 Jul;27(4):179-84. doi: 10.1016/j.blre.2013.06.002. Epub 2013 Jun 28. PubMed 23815950 ↗
Gringeri A, Leissinger C, Cortesi PA, Jo H, Fusco F, Riva S, Antmen B, Berntorp E, Biasoli C, Carpenter S, Kavakli K, Morfini M, Negrier C, Rocino A, Schramm W, Windyga J, Zulfikar B, Mantovani LG. Health-related quality of life in patients with haemophilia and inhibitors on prophylaxis with anti-inhibitor complex concentrate: results from the Pro-FEIBA study. Haemophilia. 2013 Sep;19(5):736-43. doi: 10.1111/hae.12178. Epub 2013 Jun 4. PubMed 23731246 ↗
Liu SS, White WL, Johnson PC, Gauntt C. Hemophilic pseudotumor of the spinal canal. Case report. J Neurosurg. 1988 Oct;69(4):624-7. doi: 10.3171/jns.1988.69.4.0624. PubMed 3418398 ↗
Magallon M, Monteagudo J, Altisent C, Ibanez A, Rodriguez-Perez A, Riba J, Tusell J, Martin-Villar J. Hemophilic pseudotumor: multicenter experience over a 25-year period. Am J Hematol. 1994 Feb;45(2):103-8. doi: 10.1002/ajh.2830450202. PubMed 8141115 ↗
Srivastava A, Brewer AK, Mauser-Bunschoten EP, Key NS, Kitchen S, Llinas A, Ludlam CA, Mahlangu JN, Mulder K, Poon MC, Street A; Treatment Guidelines Working Group on Behalf of The World Federation Of Hemophilia. Guidelines for the management of hemophilia. Haemophilia. 2013 Jan;19(1):e1-47. doi: 10.1111/j.1365-2516.2012.02909.x. Epub 2012 Jul 6. PubMed 22776238 ↗
van Ommeren JW, Mooren DW, Veth RP, Novakova IR, van de Kaa CA. Pseudotumor occurring in hemophilia. Arch Orthop Trauma Surg. 2000;120(7-8):476-8. doi: 10.1007/s004029900087. PubMed 10968546 ↗

Study documents

Protocol and statistical analysis plan · Jun 16, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — We will share resources and data from this project through collaborative publications in the scientific literature as well as through national, regional and international conference presentations. We will also share our methods and findings in a prompt manner with regional, national and international stakeholders to ensure that findings will be readily available to other researchers and clinicians with clinical or scientific interest in the subject area. Individual participant data that underlie the results reports in publications, reports or presentations (including text, tables, figures and appendices) will be shared after de-identification.

Supporting information: Study protocol, Sap, Csr

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03921294
Lead sponsor: Indiana Hemophilia &Thrombosis Center, Inc.
Collaborators: Genentech, Inc.
Responsible party: Amy D Shapiro, MD (Medical Director, Indiana Hemophilia &Thrombosis Center, Inc.) — Principal investigator
First posted: Apr 19, 2019
Start date: May 15, 2019
Primary completion: Mar 16, 2022
Completion: Mar 16, 2022
Results posted: Mar 20, 2024
Last update: Apr 11, 2024

Study contacts

Amy D Shapiro, MD

principal investigator · Indiana Hemophilia &Thrombosis Center, Inc.

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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HemLibra Prophylaxis in Patients With Hemophilic Pseudotumor

Study summary

Conditions studied

In context

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Related links

Study documents

Individual participant data

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies from this sponsor

Inclusion criteria

Exclusion criteria