Hemophilia ANCT07791836
Prevalence of Inhibitor Development in Hemophilia A Patients Receiving Coageight: A Multicenter Cross-sectional Observational Study
An observational study of Hemophilia A and Hemophilia, run by AryoGen Pharmed Co. at 6 sites in Iran.
Trial summary
This is a cross-sectional, observational, multi-center study to assess the prevalence of inhibitor development in hemophilia A patients receiving Coageight (rFVIII-Fc, AryoGen Pharmed Co.). Read more about this study
- Who is it for?
- Ages 2 years and older, men only
- Conditions the study is for
- Hemophilia A, Hemophilia
- What is being tested?
- efmoroctocog alfa
- How many people
- 262 participants
- Where
- 6 sitesIran
- Study dates
- 23 Aug 2026to 20 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 2 years and older
- Men only
- Child, Adult, Older adult
Study population: A total of 262 Iranian patients diagnosed with hemophilia A and treated with Coageight® (rFVIII-Fc fused, AryoGen Pharmed Co.)
Who may be able to join
- Male patients aged 2 years or older with a signed informed consent by them or their legal guardian
- Hemophilia A patients with ≥ 50 exposure days to any FVIII product, based on the patient's medical record and the physician's opinion
- History of receiving at least 10 exposure days with Coageight during the past 12 months, based on the patient's medical records and the physician's opinion
Who cannot join
- History of any other coagulation disorders except hemophilia A and disorders related to immune system deficiencies (except for the patients who have undergone Immune Tolerance Induction (ITI) treatment due to inhibitor formation)
- Patients with hepatitis B or C (based on the patient's medical records), due to potential interference with the inhibitor assessments
- Participation or intent to participate in another research study during this study period
- Inability or unwillingness of the patient to meet the protocol requirements, as determined by the physician (e.g., physical or psychological issues)
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Iran6 sites
Shahid Baqaei 2 Hospital
Ahvāz, Ahvaz, 6138933333
Bijan Keykhai, 0098 61 3375 0000, baqaei.hospital@ajums.ac.ir
Seyyed al-Shohada Hospital
Isfahan, Isfahan, 8184917354
Majid Qanavat, 0098 31 3235 0210, omid@mui.ac.ir
Soroor Clinic
Mashhad, Mashhad, 9139963185
Zahra Badiei, 0098 51 3364 5013, Sheikh.hos@mums.ac.ir
Shahid Ayatollah Dastgheib Hospital
Shiraz, Shiraz, 7145683769
Mohammadreza Bordbar, 0098 71 3228 9308, bordbarm@sums.ac.ir
Asghar Bazrafshan
Imam Khomeini Hospital
Tehran, Tehran Province, 1419733141
Mohammadreza Shaverdi, 009821 6119 0000, Imamhospital@tums.ac.ir
Mofid Children's Hospital
Tehran, Tehran Province, 1551415468
Samin Alavi Bojestani, 0098 21 2222 7021, info-mch@sbmu.ac.ir
About this study
Official title: A Cross-sectional, Observational, Multi-center Study to Assess the Prevalence of Inhibitor Development in Hemophilia A Patients Receiving Coageight (rFVIII-Fc, Manufactured by AryoGen Pharmed Co.)
This is a cross-sectional, observational, multi-center study to assess the prevalence of inhibitor development in hemophilia A patients receiving Coageight (rFVIII-Fc, AryoGen Pharmed Co.).
Read the detailed description
This is a cross-sectional, observational, multi-center study to assess the prevalence of inhibitor development in hemophilia A patients receiving Coageight (rFVIII-Fc, AryoGen Pharmed Co.). To gather the data during the predefined visit of the study, a booklet will be filled by the designated physician. The primary objective of this study is to evaluate the immunogenicity profile of Coageight by assessing the prevalence of factor VIII inhibitors in the study population, as determined by a positive Bethesda assay. The sample size of the study is set at 262 patients.
- Conditions
- Hemophilia A, Hemophilia
- Being tested
- efmoroctocog alfa
- Keywords
- Factor VIII, Coageight, Prevalence, Immunogenicity, Recombinant Factor VIII with Fc Fusion, Hemophilia A
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
efmoroctocog alfaDrug
Also called Recombinant Factor VIII with Fc Fusion, Coageight
This study assesses patients with a history of at least 10 exposure days (EDs) to recombinant factor VIII with Fc fusion (Coageight) within the 12 months prior to enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving Coageight (rFVIII-Fc, AryoGen Pharmed Co.) | Not described Receives: Drug: efmoroctocog alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the immunogenicity profile of the Coageight (rFVIII-Fc, manufactured by AryoGen Pharmed Co.)
Assessing the prevalence of inhibitors against factor VIII in the study population, as measured by a positive Bethesda test
Measured: Day 0 (-7 to 0 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start23 Aug 2026 (estimated)
- Primary completion20 Feb 2027 (estimated)
- Study completion20 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 262 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AryoGen Pharmed Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791836
- Sponsor's protocol ID
- FVIII.ARY.GT.IV.05
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Individual data sharing
- Undecided: Data regarding this study would be shared upon reasonable request from the investigator.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional, Observational, Multi-center Study to Assess the Prevalence of Inhibitor Development in Hemophilia A Patients Receiving Coageight (rFVIII-Fc, Manufactured by AryoGen Pharmed Co.)
- ClinicalTrials.gov ID
- NCT07791836
- Acronym / sponsor ID
- FVIII.ARY.GT.IV.05
- Conditions
- Hemophilia A, Hemophilia
- Keywords
- Factor VIII, Coageight, Prevalence, Immunogenicity, Recombinant Factor VIII with Fc Fusion, Hemophilia A
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 262 participants (estimated)
- Lead sponsor
- AryoGen Pharmed Co.Industry (pharma, biotech, devices)
- Study start
- 23 Aug 2026 (estimated)
- Primary completion
- 20 Feb 2027 (estimated)
- Study completion
- 20 Feb 2027 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a cross-sectional, observational, multi-center study to assess the prevalence of inhibitor development in hemophilia A patients receiving Coageight (rFVIII-Fc, AryoGen Pharmed Co.).
Detailed description
This is a cross-sectional, observational, multi-center study to assess the prevalence of inhibitor development in hemophilia A patients receiving Coageight (rFVIII-Fc, AryoGen Pharmed Co.). To gather the data during the predefined visit of the study, a booklet will be filled by the designated physician. The primary objective of this study is to evaluate the immunogenicity profile of Coageight by assessing the prevalence of factor VIII inhibitors in the study population, as determined by a positive Bethesda assay. The sample size of the study is set at 262 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving Coageight (rFVIII-Fc, AryoGen Pharmed Co.) | – | Drug: efmoroctocog alfa |
Who may qualify
- Ages
- 2 years and older
- Sex
- Male only
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 262 Iranian patients diagnosed with hemophilia A and treated with Coageight® (rFVIII-Fc fused, AryoGen Pharmed Co.)
Key inclusion criteria (3 listed)
- Male patients aged 2 years or older with a signed informed consent by them or their legal guardian
- Hemophilia A patients with ≥ 50 exposure days to any FVIII product, based on the patient's medical record and the physician's opinion
- History of receiving at least 10 exposure days with Coageight during the past 12 months, based on the patient's medical records and the physician's opinion
Key exclusion criteria (4 listed)
- History of any other coagulation disorders except hemophilia A and disorders related to immune system deficiencies (except for the patients who have undergone Immune Tolerance Induction (ITI) treatment due to inhibitor formation)
- Patients with hepatitis B or C (based on the patient's medical records), due to potential interference with the inhibitor assessments
- Participation or intent to participate in another research study during this study period
- Inability or unwillingness of the patient to meet the protocol requirements, as determined by the physician (e.g., physical or psychological issues)
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 |
|---|---|---|
| efmoroctocog alfaAlso: Recombinant Factor VIII with Fc Fusion, CoageightThis study assesses patients with a history of at least 10 exposure days (EDs) to recombinant factor VIII with Fc fusion (Coageight) within the 12 months prior to enrollment. | Drug | Patients receiving Coageight (rFVIII-Fc, AryoGen Pharmed Co.) |
Primary outcome
Evaluation of the immunogenicity profile of the Coageight (rFVIII-Fc, manufactured by AryoGen Pharmed Co.)
Time frame: Day 0 (-7 to 0 days)
Assessing the prevalence of inhibitors against factor VIII in the study population, as measured by a positive Bethesda test
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: Undecided. Data regarding this study would be shared upon reasonable request from the investigator.
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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.
6 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 and Hemophilia, run by AryoGen Pharmed Co. at 6 sites in Iran.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Iran. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hamidreza Kafi, Clinical Pharmecy Ph.D (00982143473000 ext. 141, Kafi.H@Orchidpharmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the immunogenicity profile of the Coageight (rFVIII-Fc, manufactured by AryoGen Pharmed Co.) (time frame: Day 0 (-7 to 0 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2026.