{"id":"recombinant-human-c1-inhibitor","safety":{"commonSideEffects":[{"rate":"10-20%","effect":"Injection site reactions"},{"rate":"5-10%","effect":"Headache"},{"rate":"5-10%","effect":"Nausea"},{"rate":"5-10%","effect":"Fatigue"}]},"_chembl":{"chemblId":"CHEMBL4297549","moleculeType":"Protein"},"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"The recombinant human C1 inhibitor protein is a naturally occurring regulator of the complement system, which plays a crucial role in the body's immune response. By replacing a deficient or dysfunctional C1 inhibitor protein, this drug helps to prevent excessive inflammation and tissue damage. This can be particularly beneficial for individuals with hereditary angioedema, a condition characterized by recurring episodes of severe swelling.","oneSentence":"Recombinant human C1 inhibitor works by replacing a deficient or dysfunctional C1 inhibitor protein to regulate the complement system and prevent excessive inflammation.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:31:32.645Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hereditary angioedema"}]},"trialDetails":[{"nctId":"NCT04198766","phase":"PHASE1, PHASE2","title":"Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Inhibrx Biosciences, Inc","startDate":"2019-12-10","conditions":"Solid Tumor, Non-Small Cell Lung Cancer, Head and Neck Cancer","enrollment":296},{"nctId":"NCT04705831","phase":"PHASE2","title":"Study to Evaluate the Benefit of RUCONEST in Improving Neurological Symptoms in Post COVID-19 Infection","status":"COMPLETED","sponsor":"IMMUNOe Research Centers","startDate":"2021-01-11","conditions":"Post-Viral Fatigue Syndrome, Post-Viral Disorder (Disorder), Covid19","enrollment":40},{"nctId":"NCT01397864","phase":"","title":"C1 Inhibitor Registry in the Treatment of Hereditary Angioedema (HAE) Attacks","status":"COMPLETED","sponsor":"Pharming Technologies B.V.","startDate":"2011-07","conditions":"Hereditary Angioedema","enrollment":181},{"nctId":"NCT05145283","phase":"PHASE2","title":"Recombinant Human C1 Esterase Inhibitor (Conestat Alfa) in the Prevention of Acute Ischemic Cerebral and Renal Events After Transcatheter Aortic Valve Implantation","status":"RECRUITING","sponsor":"University Hospital, Basel, Switzerland","startDate":"2022-03-16","conditions":"Acute Ischemic Stroke, Acute Renal Injury","enrollment":250},{"nctId":"NCT06690047","phase":"PHASE4","title":"Treatment of Hereditary 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B.V.","startDate":"2018-06-30","conditions":"Hereditary Angioedema","enrollment":152},{"nctId":"NCT04912141","phase":"PHASE2","title":"Prevention of Acute Kidney Injury in Patients With NSTEMI","status":"TERMINATED","sponsor":"Pharming Technologies B.V.","startDate":"2021-04-21","conditions":"Non-ST Elevation Myocardial Infarction (NSTEMI)","enrollment":29},{"nctId":"NCT01359969","phase":"PHASE2","title":"Safety of Ruconest in 2-13 Year Old Hereditary Angioedema (HAE) Patients","status":"COMPLETED","sponsor":"Pharming Technologies B.V.","startDate":"2012-01-17","conditions":"Hereditary Angioedema","enrollment":57},{"nctId":"NCT04530136","phase":"PHASE2","title":"Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19","status":"COMPLETED","sponsor":"Pharming Technologies B.V.","startDate":"2020-11-30","conditions":"Confirmed Coronavirus Disease","enrollment":38},{"nctId":"NCT04898309","phase":"PHASE2, PHASE3","title":"Efficacy and Safety of GNR-038 vs Berinert® in Patients With Hereditary Angioedema","status":"WITHDRAWN","sponsor":"AO GENERIUM","startDate":"2021-12-01","conditions":"Hereditary Angioedema","enrollment":""},{"nctId":"NCT04414631","phase":"PHASE2","title":"Conestat Alfa in the Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19","status":"TERMINATED","sponsor":"University Hospital, Basel, Switzerland","startDate":"2020-08-06","conditions":"Coronavirus Infections","enrollment":80},{"nctId":"NCT01426763","phase":"PHASE2","title":"A Study to Evaluate the Safety and Pharmacology of Subcutaneous Administration of CINRYZE With Recombinant Human Hyaluronidase","status":"COMPLETED","sponsor":"Shire","startDate":"2011-09-12","conditions":"Hereditary Angioedema","enrollment":12},{"nctId":"NCT01756157","phase":"PHASE2","title":"Subcutaneous CINRYZE With Recombinant Human Hyaluronidase for Prevention of Angioedema Attacks","status":"COMPLETED","sponsor":"Shire","startDate":"2013-02-04","conditions":"Hereditary Angioedema (HAE)","enrollment":47},{"nctId":"NCT02663687","phase":"PHASE1","title":"Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Recombinant Human C1 Esterase Inhibitor in Healthy Adult Subjects","status":"COMPLETED","sponsor":"Shire","startDate":"2016-02-19","conditions":"Hereditary Angioedema (HAE)","enrollment":48},{"nctId":"NCT03576469","phase":"PHASE4","title":"A Study to Evaluate the Benefit of RUCONEST® in Subjects Who Experience ADRs Related to IVIG Infusions","status":"COMPLETED","sponsor":"IMMUNOe Research Centers","startDate":"2018-06-13","conditions":"CVI - Common Variable Immunodeficiency","enrollment":20},{"nctId":"NCT03791476","phase":"PHASE1","title":"RUCONEST® as a Therapeutic Strategy to Reduce the Incidence of Delayed Graft Function","status":"UNKNOWN","sponsor":"University of Wisconsin, Madison","startDate":"2019-06-21","conditions":"Kidney Failure","enrollment":20},{"nctId":"NCT02869347","phase":"PHASE2","title":"Recombinant Human C1 Esterase Inhibitor in the Prevention of Contrast-induced Nephropathy in High-risk Subjects","status":"COMPLETED","sponsor":"University Hospital, Basel, Switzerland","startDate":"2017-01","conditions":"Acute Kidney Injury","enrollment":80},{"nctId":"NCT00851409","phase":"PHASE2","title":"A Study of the Safety and Immunogenicity of Repeated rhC1INH Administration","status":"COMPLETED","sponsor":"Pharming Technologies B.V.","startDate":"2009-06","conditions":"Genetic Disorders, Hereditary Angioedema","enrollment":25},{"nctId":"NCT02247739","phase":"PHASE2","title":"A Phase 2 HAE Prophylaxis Study With Recombinant Human C1 Inhibitor","status":"COMPLETED","sponsor":"Pharming Technologies B.V.","startDate":"2014-12","conditions":"Hereditary Angioedema","enrollment":32},{"nctId":"NCT01188564","phase":"PHASE3","title":"Efficacy, Safety and Immunogenicity Study of Recombinant Human C1 Inhibitor for the Treatment of Acute HAE Attacks","status":"COMPLETED","sponsor":"Pharming Technologies B.V.","startDate":"2011-01","conditions":"Hereditary Angioedema","enrollment":75},{"nctId":"NCT00261053","phase":"PHASE2","title":"Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema","status":"COMPLETED","sponsor":"Pharming Technologies B.V.","startDate":"2003-06","conditions":"Genetic Disorders","enrollment":14},{"nctId":"NCT00225147","phase":"PHASE2, PHASE3","title":"Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema","status":"COMPLETED","sponsor":"Pharming Technologies B.V.","startDate":"2005-07","conditions":"Hereditary Angioedema, Angioneurotic Edema","enrollment":77},{"nctId":"NCT00262288","phase":"PHASE2, PHASE3","title":"Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema","status":"COMPLETED","sponsor":"Pharming Technologies B.V.","startDate":"2004-04","conditions":"Genetic 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Transplantation","enrollment":""}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":44,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["\"rhC1INH\"","Ruconest","conestat alfa","rhC1INH","Conestat alfa"],"phase":"phase_3","status":"active","brandName":"recombinant human C1 inhibitor","genericName":"recombinant human C1 inhibitor","companyName":"Pharming Technologies B.V.","companyId":"pharming-technologies-b-v","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Recombinant human C1 inhibitor works by replacing a deficient or dysfunctional C1 inhibitor protein to regulate the complement system and prevent excessive inflammation. Used for Hereditary angioedema.","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"EU","regulator":"EMA","status":"refused","approval_date":null,"mah":null,"brand_name_local":"Rhucin","application_number":"EMEA/H/C/000769"},{"country_code":"GB","regulator":"MHRA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Rhucin","application_number":null}],"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}