Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2025-12-24 @ 1:36 PM
NCT ID:
NCT00418795
Eligibility Criteria:
Inclusion Criteria:
* Informed consent
* Confirmed diagnosis of AIP
* Previous attacks with PBG above the reference level of the laboratory AND exclusion of variegate porphyria (florescence emission of plasma samples is maximal at 626 nm in VP) AND exclusion of hereditary coproporphyria (HCP) (increased ratio of fecal coproporphyrin III to coproporphyrin I found in HCP)
* Acute attack of AIP verified by presence of abdominal and/or back and/or limb pain, diagnosed by the investigator as being caused by AIP
* Urine PBG above 6 mmol/mol creatinine (5 times upper reference level of the central laboratory)
* Male or female aged above 18 year
Exclusion criteria are:
* First acute attack in AIP
* Other reasons for abdominal and/or back and/or limb pain as judged by the investigator
* Therapy with human hemin within 7 days prior to administration of trial drug
* Treatment with any investigational drug within 4 weeks prior to this trial
* Known or suspected allergy to the trial product or related products
* Pregnant or breast-feeding women and women who intend to become pregnant prior to or during the trial
* Women of child-bearing potential who are not using acceptable methods of contraception (systemic contraception, IUD, barrier method or GnRH analogues)
* Previous documented renal impairment defined as above 150 mmol/L or 1.7 mg/dL serum creatinine, indicating a reduction in kidney function of 50% or more
* Any disease or condition that the investigator judges would interfere with the trial
* Previous randomization in this trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00418795
Study Brief:
Protocol Section:
NCT00418795