Completed PHASE2 INTERVENTIONAL 1-arm NCT00851409

A Study of the Safety and Immunogenicity of Repeated rhC1INH Administration (OPERA)

An Open-label Exploratory Phase II Study of the Safety and Immunogenicity of Repeated rhC1INH Administration of 50 U/Kg in Patients With Hereditary C1 Inhibitor Deficiency (HAE)

Sponsor: Pharming Technologies B.V.

Conditions Genetic Disorders Hereditary Angioedema

Interventions Recombinant Human C1 Inhibitor

Updated 9 times since 2017 Last updated: Apr 3, 2018 Started: Jun 30, 2009 Primary completion: Mar 31, 2010 Completion: Apr 30, 2010

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Genetic Disorders and Hereditary Angioedema and is currently completed. Pharming Technologies B.V. leads this study, which shows 9 recorded versions since 2009 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

9 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE2
Sep 2024 — Sep 2025 [monthly]

Completed PHASE2
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2
Jan 2023 — Jul 2024 [monthly]

Completed PHASE2
Dec 2022 — Jan 2023 [monthly]

Completed PHASE2

▶ Show 4 earlier versions

Jan 2021 — Dec 2022 [monthly]

Completed PHASE2
Jul 2018 — Jan 2021 [monthly]

Completed PHASE2
Jun 2018 — Jul 2018 [monthly]

Completed PHASE2
Jan 2017 — Jun 2018 [monthly]

Completed PHASE2

First recorded

Jun 2009

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Pharming Technologies B.V.

Data source: Pharming Technologies B.V.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Leiden, Netherlands
• Târgu Mureş, Romania