WithdrawnPhase 2/3

Efficacy and Safety of GNR-038 vs Berinert® in Patients With Hereditary Angioedema

Stopped: Company pipeline revision

Russia0Started 2021-12-01

Plain-language summary

It is a placebo-controlled randomized trial to evaluate the efficacy and safety of GNR-038 in comparison with Berinert® in patients with hereditary angioedema

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Men and women 18 years and older at the time of signing the Informed Consent Form.
✓. Availability of written informed consent signed by the patient prior to the start of any procedures related to the study.
✓. Confirmed diagnosis of HAE:
✓. Localization of the edema in the abdominal cavity, in the face area (lips, eyelids, subcutaneous tissue), limbs, trunk or in the area of the external genitals in the anamnesis.
✓. ≥4 HAE attacks requiring treatment or causing significant functional impairment for 2 consecutive months in the 3-month period prior to Screening, properly documented in the medical records.
✓. Patient's consent to adhere to reliable methods of contraception.

Exclusion criteria

✕. Deviation of the C1q level below the normal limit.
✕. B-cell lymphoproliferative diseases in the anamnesis or at the time of inclusion in clinical trial.
✕. The presence of anti-C1INH autoantibodies.
✕. Allergic reactions to the components of C1INH drugs or other blood components.
✕. Glomerular filtration rate ≤59 ml/min/1.73 m2, calculated by the formula CKD-EPI Creatinine Equation (2009) (see Appendix).
✕. The concentration of peripheral blood leukocytes \>20\*109/L.
✕. Drug addiction, solvent abuse, alcoholism in the anamnesis or at the time of inclusion.
✕. Participation in clinical trials of C1-esterase inhibitor drugs, blood transfusion and its components during the last 90 days prior to screening.

What they're measuring

Time to symptoms relief onset of acute HAE attack within 24 hours after the end of the drug administration.

Timeframe: 24 hours

Trial details

NCT IDNCT04898309

SponsorAO GENERIUM

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-05-31

View on ClinicalTrials.gov More Hereditary Angioedema trials