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Clinical trials for Porphyria

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    12 result(s) found for: Porphyria. Displaying page 1 of 1.
    EudraCT Number: 2017-002432-17 Sponsor Protocol Number: ALN-AS1-003 Start Date*: 2017-11-22
    Sponsor Name:Alnylam Pharmaceuticals, Inc.
    Full Title: ENVISION: A Phase 3 Randomized, Double-blind, Placebo-controlled Multicenter Study with an Open-label Extension to Evaluate the Efficacy and Safety of Givosiran in Patients with Acute Hepatic Porph...
    Medical condition: Acute Hepatic Porphyrias (AHP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10036182 Porphyria acute PT
    20.0 10010331 - Congenital, familial and genetic disorders 10036184 Porphyria hepatic LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) ES (Completed) DK (Completed) CZ (Completed) SE (Completed) BG (Completed) FI (Completed) BE (Completed) FR (Completed) PL (Completed) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-002638-54 Sponsor Protocol Number: ALN-AS1-002 Start Date*: 2017-12-20
    Sponsor Name:Alnylam Pharmaceuticals, Inc.
    Full Title: A Multicenter, Open-label Extension Study to Evaluate the Long-term Safety and Clinical Activity of Subcutaneously Administered ALN-AS1 in Patients with Acute Intermittent Porphyria who have Comple...
    Medical condition: Acute Intermittent Porphyria (AIP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10000818 Acute intermittent porphyria LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2018-004164-60 Sponsor Protocol Number: CUV040 Start Date*: 2022-05-19
    Sponsor Name:CLINUVEL (UK) LTD
    Full Title: A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients with Variegate Porphyria (VP)-related skin disease.
    Medical condition: Variegate Porphyria (VP)-related skin disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2007-000636-13 Sponsor Protocol Number: CUV017 Start Date*: 2008-06-17
    Sponsor Name:Clinuvel Pharmaceuticals Limited
    Full Title: A Phase III, Multicentre, Randomised, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable CUV1647 Implants in Patients with Erythropoietic Protoporphyria (EPP)
    Medical condition: Erythropoietic Protoporphyria (EPP)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10015289 Erythropoietic protoporphyria LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) SE (Completed) IT (Completed) FR (Completed) DE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2021-001831-17 Sponsor Protocol Number: MT-7117-A-301 Start Date*: 2022-04-07
    Sponsor Name:Mitsubishi Tanabe Pharma Development America (MTDA), Inc.
    Full Title: A Phase 3, Multicenter, Open-label, Long-term, Extension Study to Evaluate Safety and Tolerability of Oral Dersimelagon (MT-7117) in Subjects with Erythropoietic Protoporphyria (EPP) or X-Linked Pr...
    Medical condition: Erythropoietic Protoporphyria or X-Linked Protoporphyria
    Disease: Version SOC Term Classification Code Term Level
    24.0 100000004850 10015289 Erythropoietic protoporphyria LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) IT (Trial now transitioned) ES (Ongoing) SE (Trial now transitioned) NO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-004226-16 Sponsor Protocol Number: MT-7117-G01 Start Date*: Information not available in EudraCT
    Sponsor Name:Mitsubishi Tanabe Pharma Development America (MTDA), Inc.
    Full Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Adults and Adolescents with Erythropoietic Protoporphyria or ...
    Medical condition: Erythropoietic Protoporphyria or X-Linked Protoporphyria
    Disease: Version SOC Term Classification Code Term Level
    24.0 100000004850 10015289 Erythropoietic protoporphyria LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed) SE (Completed) GB (GB - no longer in EU/EEA) DE (Completed) FI (Prematurely Ended) IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-004903-20 Sponsor Protocol Number: ABR-38376 Start Date*: 2012-05-09
    Sponsor Name:
    Full Title: Hydroxychloroquine as an anti-autophagy and chromatin modulating drug in combination with erlotinib in non-small cell lung cancer (NSCLC) patients: a single-center single arm open-label phase II trial
    Medical condition: Patients with histologically confirmed stage IV non-squamous non-small-cell lung cancer (NSCLC) • with an activating EGFR mutation who progressed on erlotinib or gefitinib monotherapy. OR • who...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-002863-28 Sponsor Protocol Number: EPP001 Start Date*: 2007-09-26
    Sponsor Name:Guy's & St Thomas' NHS Foundation Trust
    Full Title: Investigation into the use of colestyramine as a therapy for patients with erythropoietic protoporphyria
    Medical condition: Erythropoietic protoporphyria (EPP)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10015289 Erythropoietic protoporphyria LLT
    Population Age: Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-011018-51 Sponsor Protocol Number: CUV029 Start Date*: 2009-08-06
    Sponsor Name:Clinuvel Pharmaceuticals Limited
    Full Title: A Phase III, Multicentre, Double-Blind, Randomised, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients with Erythropoietic ...
    Medical condition: Erythropoietic Protoporphyria (EPP)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10015289 Erythropoietic protoporphyria LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) FI (Completed) GB (Completed) IE (Completed)
    Trial results: View results
    EudraCT Number: 2021-001685-38 Sponsor Protocol Number: 2693-CL-0312 Start Date*: 2021-11-24
    Sponsor Name:Astellas Pharma Global Development, Inc.
    Full Title: A Phase 3b, Randomized, Double-blind, Placebo-controlled, 24-week Study to Assess the Efficacy and Safety of Fezolinetant in Menopausal Women Suffering from Moderate to Severe Vasomotor Symptoms (H...
    Medical condition: Moderate to Severe Vasomotor Symptoms (Hot Flashes) Associated with Menopause
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004866 10020407 Hot flashes LLT
    Population Age: Adults Gender: Female
    Trial protocol: CZ (Completed) ES (Ongoing) IT (Completed) HU (Completed) FI (Completed) NL (Completed) NO (Completed) DE (Completed) PL (Completed) DK (Completed) BE (Completed) SK (Prematurely Ended) BG (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-004795-39 Sponsor Protocol Number: LSO-OL005 Start Date*: 2008-06-12
    Sponsor Name:Light Sciences Oncology Inc.
    Full Title: A Phase III Randomised Study to Evaluate Survival of Patients Treated with Talaporfin Sodium (LS11) and Interstitial Light Emitting Diodes (LED) as Compared to the Standard of Care Therapies in the...
    Medical condition: Patients with unresectable hepatocellular carcinoma
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10019828 Hepatocellular carcinoma non-resectable LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed) SE (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2004-000193-31 Sponsor Protocol Number: PR08 Start Date*: 2004-10-04
    Sponsor Name: University College London
    Full Title: Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy
    Medical condition: Prostate Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10001186 Adenocarcinoma of prostate LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10001198 Adenocarcinoma of the prostate metastatic LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10001199 Adenocarcinoma of the prostate recurrent LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10007113 Cancer of prostate LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10007453 Carcinoma of the prostate metastatic LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10007454 Carcinoma of the prostate recurrent LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10007462 Carcinoma prostate LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10060862 Prostate cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10060862 Prostate cancer PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036911 Prostate cancer recurrent PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036911 Prostate cancer recurrent PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036921 Prostate carcinoma LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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