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Proof of Concept Study to Assess the Efficacy, Safety of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06051357
Recruitment Status : Not yet recruiting
First Posted : September 22, 2023
Last Update Posted : September 22, 2023
Sponsor:
Information provided by (Responsible Party):
Chengdu Suncadia Medicine Co., Ltd.

Brief Summary:
This is a multicenter, randomized, open-label phase II clinical trial. A total of 24 patients with paroxysmal nocturnal hemoglobinuria naïve to complement inhibitor therapy were included. Subjects were treated with HRS-5965 for 12 weeks.

Condition or disease Intervention/treatment Phase
Paroxysmal Nocturnal Hemoglobinuria Drug: HRS-5965 tablets Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Multicenter, Randomized, Open-label Proof of Concept Study to Assess the Efficacy, Safety of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Estimated Study Start Date : September 2023
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024


Arm Intervention/treatment
Experimental: Treatment group A Drug: HRS-5965 tablets
HRS-5965 tablets for 12 weeks

Experimental: Treatment group B Drug: HRS-5965 tablets
HRS-5965 tablets for 12 weeks




Primary Outcome Measures :
  1. Changes in hemoglobin. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Changes in LDH. [ Time Frame: 12 weeks ]
  2. Changes in haptoglobin. [ Time Frame: 12 weeks ]
  3. Changes in bilirubin. [ Time Frame: 12 weeks ]
  4. Changes in reticulocyte counts. [ Time Frame: 12weeks ]
  5. Changes in C3 complement fragment deposition. [ Time Frame: 12 week ]
  6. Percentage of patients who did not receive a blood transfusion. [ Time Frame: 12 weeks ]
  7. Number of RBC units of transfused. [ Time Frame: 12weeks ]
  8. Incidence and severity of adverse events [ Time Frame: 16 weeks ]
  9. Incidence of thromboembolic events. [ Time Frame: 16 weeks ]
  10. Plasma concentration of HRS-5965. [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of PNH confirmed by flow cytometry with clone size ≥ 10%.
  2. Have not received complement inhibitor therapy ;
  3. LDH > 1.5×ULN;
  4. Hemoglobin level < 10 g/dL.

Exclusion Criteria:

  1. Known or suspected hereditary or acquired complement deficiency;
  2. Patients with laboratory evidence of bone marrow failure (reticulocytes <100x109/L; platelets <30x109/L; neutrophils <0.5x109/L);
  3. Presence or suspicion of a systemic active bacterial, viral, or fungal infection (based on judgment of the investigator) within 2 weeks prior to the first dose of HRS-5965;
  4. History of infection with capsular bacteria (e.g., meningococcus, pneumococcus, etc.)
  5. Positive of HIV, HBsAg or HCVAb.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06051357


Contacts
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Contact: Luyao Dong 0518-82342973 luyao.dong@hengrui.com
Contact: Bin Hu +86 18210289829 bin.hu5@hengrui.com

Sponsors and Collaborators
Chengdu Suncadia Medicine Co., Ltd.
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Responsible Party: Chengdu Suncadia Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT06051357    
Other Study ID Numbers: HRS-5965-202
First Posted: September 22, 2023    Key Record Dates
Last Update Posted: September 22, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemoglobinuria
Hemoglobinuria, Paroxysmal
Proteinuria
Urination Disorders
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Urological Manifestations
Anemia, Hemolytic
Anemia
Hematologic Diseases
Myelodysplastic Syndromes
Bone Marrow Diseases