Hemophilia ANCT03169972

ADYNOVATE Drug Use-Results Survey

An observational study of Hemophilia A, run by Takeda at 52 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this survey is to understand the following items in the actual clinical use of ADYNOVATE in patients: 1. Unexpected adverse drug reactions 2. Occurrence of adverse drug reactions in the actual clinical use 3. Factors that may affect safety and efficacy 4. Read more about this study

Who is it for?: Any age
Conditions the study is for: Hemophilia A
What is being tested?: ADYNOVATE
How many people: 135 participants
Where: 52 sitesJapan
Study dates: 1 Feb 2017to 15 Sep 2023
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients with hemophilia A (congenital blood coagulation factor VIII deficiency) who receive ADYNOVATE

Who may be able to join

Hemophilia A patients who receive ADYNOVATE, including previously treated patients with Factor VIII deficiency (PTPs), and previously untreated patients with Factor VIII deficiency (PUPs) who are treated with ADYNOVATE.

Who cannot join

Patients not administered ADYNOVATE.

Trial locations and contacts

52 sites in 1 country.

City, postcode or hospital

52 sites in 1 country

Japan52 sites

Chiba-City, Japan
Chiba, Chiba, 260-8677
Fukuoka-City, Japan
Fukuoka, Fukuoka, 812-8582
Higashiosaka City
Higashiosaka, Osaka, 578-8588
Hirakata City
Hirakata, Osaka, 573-1191
Hirosaki City
Hirosaki, Aomori, 036-8004
Hiroshima City, Japan
Hiroshima, Hiroshima, 734-8551
Jyoetsu City
Jyoetsu City, Niigata, 943-0147
Kagoshima City, Japan
Kagoshima, Kagoshima-ken, 890-0046
Kashiwazaki City
Kashiwazaki, Niigata, 945-0035
Kawasaki City, Japan
Kawasaki, Kanagawa, 216-8511
Kitakyusyu City, Japan
Kitakyushu, Fukuoka, 805-0050
Kitakyusyu City, Japan
Kitakyushu, Fukuoka, 807-8556
Kobe City
Kobe, Hyōgo, 650-0047
Kobe City
Kobe, Hyōgo, 651-2273
Koti City, Japan
Kochi, Koti Prefecture, 781-8555
Koriyama City
Kōriyama, Fukushima, 963-8585
Koshigaya City, Japan
Koshigaya, Saitama, 343-8555
Kudou-Gun, Japan
Kudou-Gun, Hokkaido, 049-4501
Kurasiki City, Japan
Kurashiki, Okayama-ken, 701-0192
Kyoto City
Kyoto, Kyoto, 605-0981
Maebashi City
Maebashi, Gunma, 371-8511
Matsudo City, Japan
Matsudo, Chiba, 271-8511
Matsumoto City
Matsumoto, Nagano, 390-8621
Matsuyama City, Japan
Matsuyama, Ehime, 790-8524
Minamata City, Japan
Minamata, Kumamoto, 867-0041
Morioka City, Japan
Morioka, Iwate, 020-8560
Nagano City, Japan
Nagano, Nagano, 380-0928
Nagoya City, Japan
Nagoya, Aichi-ken, 466-8560
Narita City
Narita, Chiba, 286-8523
Nichinan City
Nichinan, Miyazaki, 887-0013
Nishi-ku
Nishi-ku, Osaka, 593-8304
Nishinomiya City, Japan
Nishinomiya, Hyōgo, 633-8501
Ogaki City, Japan
Ōgaki, Gifu, 503-8502
Okayama City, Japan
Okayama, Okayama-ken, 700-8558
Osaka City, Japan
Osaka, Osaka, 540-0006
Osaka-City, Japan
Osaka, Osaka, 554-0012
Saitama-City, Japan
Saitama, Saitama, 330-8777
Sakata City, Japan
Sakata, Yamagata, 998-8501
Sapporo City
Sapporo, Hokkaido, 060-8648
Sendai City
Sendai, Miyagi, 983-8520
Setagaya-ku, Japan
Setagaya-ku, Tokyo Metropolitan, 157-8535
Shinjuku-Ku, Japan
Shinjuku-Ku, Tokyo, 160-0023
Shunan City, Japan
Shunan City, Yamagata, 745-8522
Suginami-ku, Japan
Suginami-ku, Tokyo, 167-0035
Sukagawa City
Sukagawa, Fukushima, 962-8507
Tokushima City, Japan
Tokushima, Tokushima, 770-8503
Tome City, Japan
Tome, Miyagi, 987-0511
Toon City
Tōon, Ehime, 791-0295
Tsu City, Japan
Tsu, Mie-ken, 514-8507
Yokohama City, Japan
Yokohama, Kanagawa, 232-8555
Yokohama City, Japan
Yokohama, Kanagawa, 241-0811
Zentuji City, Japan
Zentuji City, Kagawa-ken, 765-8501

Other trials in Japan

About this study

The purpose of this survey is to understand the following items in the actual clinical use of ADYNOVATE in patients:

Unexpected adverse drug reactions
Occurrence of adverse drug reactions in the actual clinical use
Factors that may affect safety and efficacy
Occurrence of Factor VIII inhibitor development in patients with coagulation factor VIII deficiency (hereinafter hemophilia A)
Safety and efficacy for hemophilia A patients who received routine prophylactic therapy and on-demand therapy

Conditions: Hemophilia A
Being tested: ADYNOVATE
Medical subject headings: Hemophilia A

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ADYNOVATEBiological
Also called BAX 855, BAX855, Recombinant Factor VIII (FVIII) PEGylated
Antihemophilic Factor (Recombinant), PEGylated

Study groups in NCT03169972
Study group	Role	What they receive
Previously treated patients (PTPs)		PTPs: patients who had 4 or more days to other Factor VIII (FVIII) products Receives: Biological: ADYNOVATE
Previously untreated patients (PUPs)		PUPs: patients who had 3 or less previous exposure days to other products Receives: Biological: ADYNOVATE

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Discontinued the Use of Study Drug
Number of previously treated patients (PTPs) and previously untreated patients (PUPs) who discontinued the use of ADYNOVATE were reported.
Measured: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
Annual Bleed Rate (ABR) of Spontaneous Bleeding Episodes on a Prophylaxis Regimen
Annual bleed rate (ABR) of spontaneous bleeding episodes in PTPs and PUPs on a prophylaxis regimen were reported. Annual bleed rate is calculated by the number of bleeding episodes observed during administration period divided by the duration of administration period, after that multiplied with 365.2425.
Measured: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
Annual Bleed Rate (ABR) of Breakthrough Bleeding Episodes on a Prophylaxis Regimen
Annual bleed rate (ABR) of breakthrough bleeding episodes in PTPs and PUPs on a prophylaxis regimen were reported. Annual bleed rate is calculated by the number of bleeding episodes observed during administration period divided by the duration of administration period, after that multiplied with 365.2425.
Measured: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
Duration of Treatment of Study Drug on a Prophylaxis Regimen
Duration of treatment of study drug on a prophylaxis regimen was reported.
Measured: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs.
Duration of Treatment of Study Drug an On-Demand Regimen
Duration of treatment of study drug on an on-demand regimen was reported.
Measured: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
Dose Per Administration of Study Drug on a Prophylaxis Regimen
Dose per administration of study drug on a prophylaxis regimen was reported.
Measured: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
Dose Per Administration of Study Drug an On-Demand Regimen
Dose per administration of study drug on an on-demand regimen was reported.
Measured: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
Number of Doses Per a Bleeding Episode of Study Drug an On-Demand Regimen
Number of doses per a bleeding episode of study drug on an on-demand regimen was reported.
Measured: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
Hemostatic Effectiveness of Study Drug on Treatment of Breakthrough Bleeding Episodes With a Prophylaxis Regimen
Percentage of each category of hemostatic effectiveness for treatment of breakthrough bleeding episodes in a prophylaxis regimen assessed by the investigator was reported. Hemostatic effectiveness was assessed by the investigator with following 4-point ordinal scale: Excellent, Good, Fair, Poor.
Measured: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
Hemostatic Effectiveness of Study Drug on an On-Demand Regimen
Percentage of each category of hemostatic effectiveness for an on-demand regimen assessed by the investigator was reported. Hemostatic effectiveness was assessed by the investigator with following 4-point ordinal scale: Excellent, Good, Fair, Poor.
Measured: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs

Secondary outcomes (2)

Number of Doses Per a Week of Study Drug on a Prophylaxis Regimen
Number of doses per a week of study drug on a prophylaxis regimen was reported.
Measured: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
Number of Participants Who Experience Factor VIII Inhibition, Dermatitis Atopic or Eczema as an Adverse Event (AE)
Number of PTPs and PUPs who experienced factor VIII inhibition, dermatitis atopic or eczema as an AE related to development of inhibitors, shock or anaphylaxis was reported.
Measured: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 201715 Sep 2023

First posted30 May 2017
Study start1 Feb 2017
Primary completion15 Sep 2023
Study completion15 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hemophilia AStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 135 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03169972
Sponsor's protocol ID: 261601
Status last verified: Feb 2025
First submitted: 25 May 2017
Last updated: 4 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged 1 to Less Than 12 Years With Hemophilia A or B
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All Hemophilia A trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ADYNOVATE Drug Use-Results Survey
ClinicalTrials.gov ID: NCT03169972
Acronym / sponsor ID: 261601
Conditions: Hemophilia A
Study type: Observational
Recruitment status: Completed
Enrolment: 135 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 1 Feb 2017 (actual)
Primary completion: 15 Sep 2023 (actual)
Study completion: 15 Sep 2023 (actual)
First posted: 30 May 2017 (actual)
Results: Posted 4 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this survey is to understand the following items in the actual clinical use of ADYNOVATE in patients:

Unexpected adverse drug reactions
Occurrence of adverse drug reactions in the actual clinical use
Factors that may affect safety and efficacy
Occurrence of Factor VIII inhibitor development in patients with coagulation factor VIII deficiency (hereinafter hemophilia A)
Safety and efficacy for hemophilia A patients who received routine prophylactic therapy and on-demand therapy

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Previously treated patients (PTPs)	–	Biological: ADYNOVATEPTPs: patients who had 4 or more days to other Factor VIII (FVIII) products
Previously untreated patients (PUPs)	–	Biological: ADYNOVATEPUPs: patients who had 3 or less previous exposure days to other products

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients with hemophilia A (congenital blood coagulation factor VIII deficiency) who receive ADYNOVATE

Key inclusion criteria (1 listed)

Hemophilia A patients who receive ADYNOVATE, including previously treated patients with Factor VIII deficiency (PTPs), and previously untreated patients with Factor VIII deficiency (PUPs) who are treated with ADYNOVATE.

Key exclusion criteria (1 listed)

Patients not administered ADYNOVATE.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ADYNOVATEAlso: BAX 855, BAX855, Recombinant Factor VIII (FVIII) PEGylatedAntihemophilic Factor (Recombinant), PEGylated	Biological	Previously treated patients (PTPs), Previously untreated patients (PUPs)

Primary outcome

Number of Participants Who Discontinued the Use of Study Drug
Time frame: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
Number of previously treated patients (PTPs) and previously untreated patients (PUPs) who discontinued the use of ADYNOVATE were reported.
Annual Bleed Rate (ABR) of Spontaneous Bleeding Episodes on a Prophylaxis Regimen
Time frame: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
Annual bleed rate (ABR) of spontaneous bleeding episodes in PTPs and PUPs on a prophylaxis regimen were reported. Annual bleed rate is calculated by the number of bleeding episodes observed during administration period divided by the duration of administration period, after that multiplied with 365.2425.
Annual Bleed Rate (ABR) of Breakthrough Bleeding Episodes on a Prophylaxis Regimen
Time frame: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
Annual bleed rate (ABR) of breakthrough bleeding episodes in PTPs and PUPs on a prophylaxis regimen were reported. Annual bleed rate is calculated by the number of bleeding episodes observed during administration period divided by the duration of administration period, after that multiplied with 365.2425.
Duration of Treatment of Study Drug on a Prophylaxis Regimen
Time frame: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs.
Duration of treatment of study drug on a prophylaxis regimen was reported.
Duration of Treatment of Study Drug an On-Demand Regimen
Time frame: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
Duration of treatment of study drug on an on-demand regimen was reported.
Dose Per Administration of Study Drug on a Prophylaxis Regimen
Time frame: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
Dose per administration of study drug on a prophylaxis regimen was reported.
Dose Per Administration of Study Drug an On-Demand Regimen
Time frame: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
Dose per administration of study drug on an on-demand regimen was reported.
Number of Doses Per a Bleeding Episode of Study Drug an On-Demand Regimen
Time frame: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
Number of doses per a bleeding episode of study drug on an on-demand regimen was reported.
Hemostatic Effectiveness of Study Drug on Treatment of Breakthrough Bleeding Episodes With a Prophylaxis Regimen
Time frame: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
Percentage of each category of hemostatic effectiveness for treatment of breakthrough bleeding episodes in a prophylaxis regimen assessed by the investigator was reported. Hemostatic effectiveness was assessed by the investigator with following 4-point ordinal scale: Excellent, Good, Fair, Poor.
Hemostatic Effectiveness of Study Drug on an On-Demand Regimen
Time frame: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
Percentage of each category of hemostatic effectiveness for an on-demand regimen assessed by the investigator was reported. Hemostatic effectiveness was assessed by the investigator with following 4-point ordinal scale: Excellent, Good, Fair, Poor.

2 secondary outcomes

Number of Doses Per a Week of Study Drug on a Prophylaxis Regimen
Time frame: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
Number of Participants Who Experience Factor VIII Inhibition, Dermatitis Atopic or Eczema as an Adverse Event (AE)
Time frame: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs

Results and safety

Results posted to the registry on 4 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Previously Treated Patients (PTPs)	123	123
Previously Untreated Patients (PUPs)	12	12

Primary outcome: Number of Participants Who Discontinued the Use of Study Drug

Time frame: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs. Count of participants. Unit: Participants

Measure	Previously Treated Patients (PTPs) n = 123	Previously Untreated Patients (PUPs) n = 12
Value	10	5

Population analysed: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.

Primary outcome: Annual Bleed Rate (ABR) of Spontaneous Bleeding Episodes on a Prophylaxis Regimen

Time frame: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs. Median (Inter-Quartile Range). Unit: Bleeds per year

Measure	Previously Treated Patients (PTPs) n = 24	Previously Untreated Patients (PUPs) n = 0
Value	1.99 (1.00 to 3.59)	–

Population analysed: Efficacy analysis set: all participants who received at least one dose of protocol treatment without major protocol deviation. The number analyzed was the number of participants with data available for analysis who treated with a prophylaxis regimen and experienced spontaneous bleeding episodes during the administration period.

Primary outcome: Annual Bleed Rate (ABR) of Breakthrough Bleeding Episodes on a Prophylaxis Regimen

Measure	Previously Treated Patients (PTPs) n = 31	Previously Untreated Patients (PUPs) n = 1
Value	3.16 (1.11 to 5.10)	2.91 (2.91 to 2.91)

Population analysed: Efficacy analysis set: all participants who received at least one dose of protocol treatment without major protocol deviation. The number analyzed was the number of participants with data available for analysis who treated with a prophylaxis regimen and experienced breakthrough bleeding episodes during the administration period.

Primary outcome: Duration of Treatment of Study Drug on a Prophylaxis Regimen

Time frame: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs.. Mean (Standard Deviation). Unit: days

Measure	Previously Treated Patients (PTPs) n = 110	Previously Untreated Patients (PUPs) n = 7
Value	343.0 (69.33)	510.7 (256.04)

Population analysed: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. The number analyzed was the number of participants with data available for analysis who treated with a prophylaxis regimen during the administration period.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 1 year for previously treated patients (PTPs) or up to 2 years for previously untreated patients (PUPs). Other adverse events reported at 5.0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Previously Treated Patients (PTPs)	2 of 123 (1.6%)	1 of 123 (0.8%)	0 of 123
Previously Untreated Patients (PUPs)	1 of 12 (8.3%)	5 of 12 (41.7%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain more information on the study, click here/on this linkLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

Related trials for Hemophilia A

Not yet recruitingPhase 1
Lentiviral FVIII Gene Therapy
Hemophilia A
RecruitingPhase 1/2
A First-in Human Study of ARD001 in Healthy Volunteers and People With Hemophilia A
Hemophilia A, Healthy Adult Participants
RecruitingPhase 3
A Research Study Investigating Denecimig (Mim8) in Adults With Acquired Haemophilia A
Haemophilia A
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged 1 to Less Than 12 Years With Hemophilia A or B
Hemophilia
RecruitingObservational study
An Observational Study to Learn More About How Well Damoctocog Alfa Pegol Works in Previously Treated Children With Hemophilia A
Hemophilia A

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director study director

Takeda

52 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hemophilia A, run by Takeda at 52 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Discontinued the Use of Study Drug (time frame: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03169972.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.