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Clinical study for omalizumab in the treatment of hereditary bullous epidermolysis

Clinical study for omalizumab in the treatment of hereditary bullous epidermolysis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900021437
Enrollment
Unknown
Registered
2019-02-21
Start date
2019-03-10
Completion date
Unknown
Last updated
2019-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

inherited epidermolysis bullosa

Interventions

Case series:Omabizumab subcutaneous injection

Sponsors

Xinhua Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Subjects (or guardians) voluntarily sign the informed consent of the trial; 2) Patients with hereditary epidermolysis bullosa (hereditary epidermolysis bullosa) who are older than or equal to 2 years old and younger than or equal to 80 years old, regardless of gender; 3) Patients with moderate to severe itching, itching score > 6, and IgE increased; 4) Subjects were able to follow the drug dosage and visit plan; 5) Can objectively describe symptoms, no serious infection, respiratory insufficiency, etc., can actively cooperate; 6) Non-allergic diseases and non-allergic constitutions; 7) Contraindicated patients with non-Omazumab drugs; 8)

Exclusion criteria

Exclusion criteria: 1) those with asthma, allergic rhinitis and milk allergy; 2) The general situation is poor, and the symptoms can not be described objectively, or there are serious infections, respiratory insufficiency, etc. can not cooperate actively; 3) Patients with severe respiratory system, cardiovascular system diseases, liver and kidney dysfunction and malignant tumors; 4) Patients with allergic reaction to the active ingredient of Omazumab or any other excipient (the active ingredient is Omazumab; the excipients include sucrose, L-histidine, L-histidine hydrochloride monohydrate and polysorbide 20); 5) Patients with total IgE 1 500 IU/ml; 6) suspected or confirmed history of drug abuse and addiction; 7) Lactating and pregnant women: subjects (including male subjects) who had no pregnancy plan within one month after the trial; 8) Patients who had participated in the drug test within 3 months before the trial (including the drug in the trial); 9) Bidders or researchers directly involved in the experiment or their family members; 10) Researchers believe that there are any reasons why they cannot be selected.

Design outcomes

Primary

MeasureTime frame
Itching score;Itching score;

Secondary

MeasureTime frame
Anxiety and depression score;Anxiety and depression score;

Countries

China

Contacts

Public ContactZhirong Yao

Xinhua Hospital, Shanghai Jiaotong University School of Medicine

zryaoxh@sina.com+86 2125078570

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 14, 2026