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Hemophilia A With InhibitorPhase 1NCT05651061

A Phase I of SS109 in Hemophilia A or and B With Inhibitors

A Phase 1 study testing SS109 in people with Hemophilia A With Inhibitor and Hemophilia B With Inhibitor, run by Hangzhou Gensciences Biopharmaceutical Co., Ltd. at 10 sites in China.

Completed

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

Official record
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Trial summary

This phase I study aims to evaluate the safety, PK/PD and immunogenicity of SS109 in hemophilia A or and B with inhibitors. Twenty -seven patients are enrolled in study, and divided into five dose cohorts, from 30μg/kg to 360μg/kg. Dose 1 cohort enrolls three patients, each other dose cohorts enroll six patients. Read more about this study

Who is it for?
Ages 18 to 65 years, men only
What is being tested?
SS109
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
10 sitesChina
Study dates
14 Dec 2022to 15 Aug 2023
Phase
Phase 1
Are there results?
None posted in the registry

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 18 to 65 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age was 18 to 65 years old，when signing the informed consent form, male;
  • Clinical diagnosis of hemophilia A or B (previous or screening period FⅧ activity level≤ 1% or FⅨ activity level≤ 2%), and there is one of the following conditions:
  • FⅧ or FⅨ inhibitor level ≥ 5Bu/mL during screening period;
  • During the screening period, the level of FⅧ and FⅨ inhibitors was less than 5 Bu/mL and more than 0.6 Bu/mL, but had a high response to factor Ⅷ or IX injection (such as, the patient had a positive history of FⅧ/FⅨ inhibitors, and then the inhibitor level is ≥ 5Bu/mL, after the second infusion of FⅧ/FⅨ);
  • No active bleeding symptoms before the first injection;
  • Patients can comply with the requirements of the protocol and be willing to complete the study as planned and provide biological samples for test;
  • Be able to understand the procedures and methods of this clinical trial. The patient voluntarily participates and signs by himself or by the impartial witness

Who cannot join

  • Patients with known history of hypersensitivity to the investigational drug preparation and any of its components;
  • There was hypersensitivity or anaphylaxis after FⅦ or IgG2 injection treatment in the past;
  • Patients with FⅦ inhibitor positive or with FⅦ inhibitor positive history in screening period;
  • Severe anemia (hemoglobin < 60g/L);
  • Platelet count < 100 × 109/L；
  • Patients with abnormal liver and kidney functions: alanine aminotransferase (ALT) or aspartate aminotransferase (AST)≥ 2.5 times the upper limit of normal value (ULN), or total bilirubin ≥ 1.5 times ULN; or blood creatinine (Cr) ≥ 1.5 times;
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  • One or more tests are positive, such as HBsAg, HCV antibody, anti-human immunity for HIV antibody and anti-treponema pallidum specific antibody (TPHA);
  • Except for hemophilia A or B, the coagulation indexes of any other bleeding disease or other diseases are obviously different(such as platelet disease, vitamin K deficiency, etc.);
  • History or symptoms of any previous arterial or venous thromboembolism event (such as atherosclerosis, myocardial infarction, ischemic stroke, transient ischemic attack, deep vein thrombosis or pulmonary hypertension, pulmonary embolism), or patients with history of disseminated intravascular coagulation (DIC);
  • Suffered from serious heart disease, such as unstable angina, congestive heart failure (New York Heart Association, ≥ Grade III), severe arrhythmia (QTc interval>450ms, corrected by Fridericia formula), hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 95 mmHg) not controlled by treatment;
  • Receive any product containing FⅦ or FⅦa (plasma derived or recombinate) within 48 hours before the first injection;
  • Receive any product containing FⅧ (plasma derived or recombinate) within 72 hours before the first injection; or receive any product containing FIX (plasma derived or recombinate) within 96 hours before administration;
  • Patients have used any anticoagulant, anti-fibrinol solvent, chemical, biological products or traditional Chinese medicine that affect platelet function within one week before the first injection or need to use any anticoagulant, anti-fibrinol solvent during PK/PD period, including non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin;
  • Patients have received immunomodulator (such as gamma globulin α- Interferon and prednisone>10mg/d [and>7 days] or similar drugs, except antiretroviral drugs);
  • Patients who received whole blood or plasma treatment within 2 weeks before the first injection;
  • Patients who have received vaccines within 4 weeks or planned to be vaccinated during the trial before the first injection;
  • Major surgery (such as orthopedic surgery and abdominal surgery) was performed within 1 month before the first injection, or planned to undergo surgery during the study;
  • Patients who have been selected into other clinical trials within 1 month before the first injection;
  • Patients with a history of drug abuse or alcohol abuse (alcohol abuse standard: male with a long-term alcohol consumption history of more than 5 years, equivalent to alcohol ≥ 40g/d, ≥ 20g/d for women, or a history of heavy drinking within 2 weeks, with the equivalent alcohol volume > 80g/d.
  • Patients suffering from mental illness or obvious mental disorder, or incapacity and lack of cognition caused by other reasons
  • A birth plan or sperm donation plan from the study to 3 months after the study, or patients are unwilling to take contraceptive measures (such as condoms, diaphragms, intrauterine devices, etc.);
  • A disease with clinical significance or other reasons that the researcher thinks patients are not suitable for participating in this clinical trial (if patients cannot benefit from clinical trials);
  • The investigator considers patients with poor compliance, and patients will be impossible to evaluate the efficacy or accomplish the course of treatment and follow-up.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

China10 sites

  • Xiangya Hospital, Central South University

    Changsha, Hunan

  • Anhui Provincial Hospital

    Hefei, Anhui

  • The First Affiliated Hospital of Shandong First Medical University

    Jinan, Shandong

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi

  • The Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi

  • Hematology Hospital, Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality

  • Xi'an Central Hospital

    Xi’an, Shanxi

  • Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu

  • Henan Provincial Cancer Hospital

    Zhengzhou, Henan

Other trials in China

About this study

Official title: To Evaluate the Safety, PK/PD and Immunogenicity of SS109 in Hemophilia Patients With Blood Coagulation Factor Ⅷ or Ⅸ Inhibitors After Single Administration, Open Label, Dose Escalation, and Multicenter Phase I Clinical Trial

This phase I study aims to evaluate the safety, PK/PD and immunogenicity of SS109 in hemophilia A or and B with inhibitors. Twenty -seven patients are enrolled in study, and divided into five dose cohorts, from 30μg/kg to 360μg/kg. Dose 1 cohort enrolls three patients, each other dose cohorts enroll six patients. All patients included in the study will continue to be followed up until 28 days after SS109 administration.

Read the detailed description

This study is an open label, dose escalation, multicenter clinical trial. The study sets up a science review committee to assess the dose escalation. Serial blood samples for PK/PD analysis will be taken up to 72 hours after SS109 injection. Patients safety will be routinely monitored throughout the study.

Being tested
SS109
Medical subject headings
Factor VII Deficiency

What participants receive

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

  • SS109Biological

    27 patients are enrolled in cohorts ,and will continue to be followed up until 28 days after SS109 administration for evaluating safety, PK/PD and immunogenicity.

Study groups in NCT05651061
Study groupRoleWhat they receive
Dose cohortsExperimentalDose cohorts were designed to evaluate the safety, immunogenicity and PK/PD.
Receives: Biological: SS109

What is being measured

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

  1. The incidence of adverse event/serious adverse event/specical interest adverse event(AE/SAE/AESI)

    AE/SAE/AESI is any untoward clinical signs, symptoms or outcomes

    Measured: Up to 28 days after SS109 injected

  2. Number of patients with positive FVII inhibitor, anti- drug antibody (ADA)

    Number of patients with positive FVII inhibitor, anti drug antibody (ADA)

    Measured: Up to 28 days after SS109 injected

Secondary outcomes (10)

  1. t½

    Half-life

    Measured: Up to 72 hours after SS109 injected

  2. Cmax

    Maximum concentration

    Measured: Up to 72 hours after SS109 injected

  3. Tmax

    Time to reach maximum concentration

    Measured: Up to 72 hours after SS109 injected

  4. AUC0-last

    Area under the curve from 0 to last

    Measured: Up to 72 hours after SS109 injected

  5. AUC0-72

    Area under the curve from 0 to 72 hour

    Measured: Up to 72 hours after SS109 injected

  6. AUC0-∞

    Area under the curve from 0 to ∞

    Measured: Up to 72 hours after SS109 injected

  7. CL

    Clearance

    Measured: Up to 72 hours after SS109 injected

  8. Vd

    Volume of distribution

    Measured: Up to 72 hours after SS109 injected

  9. MRT

    Mean residence time

    Measured: Up to 72 hours after SS109 injected

  10. IR

    Incremental recovery rate

    Measured: Up to 72 hours after SS109 injected

Timeline

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

  1. First posted14 Dec 2022
  2. Study start14 Dec 2022
  3. Primary completion31 Mar 2023
  4. Study completion15 Aug 2023

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05651061
Sponsor's protocol ID
CTR20222792
Status last verified
May 2023
First submitted
29 Nov 2022
Last updated
22 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SS109 in people with Hemophilia A With Inhibitor and Hemophilia B With Inhibitor, run by Hangzhou Gensciences Biopharmaceutical Co., Ltd. at 10 sites in China.

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 7 inclusion and 23 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 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The incidence of adverse event/serious adverse event/specical interest adverse event(AE/SAE/AESI) (time frame: Up to 28 days after SS109 injected). The study lists 2 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 NCT05651061.

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 22 Aug 2023.

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