Skip to main content
Clinical Trials/EUCTR2017-004776-56-IS
EUCTR2017-004776-56-IS
Active, not recruiting
Phase 1

Phase IIa Biomarker Study to Evaluate the Efficacy, Safety and Tolerability of AT-1 in Patients with Hereditary Cystatin C Amyloid Angiopathy (HCCAA) - the AT1-HCCAA study

Arctic Therapeutics ehf0 sites50 target enrollmentSeptember 19, 2018

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Hereditary Cystatin C Amyloid Angiopathy (HCCAA)
Sponsor
Arctic Therapeutics ehf
Enrollment
50
Status
Active, not recruiting
Last Updated
7 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 19, 2018
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Arctic Therapeutics ehf

Eligibility Criteria

Inclusion Criteria

  • Inclusion Criteria
  • 1Patient is male or female, ages 18 or older, of Icelandic ancestry known to carry the HCCAA mutation L68Q.
  • 2Patient is judged to be in sufficient medical health to be able to participate in the study.
  • 3Patient has HCCAA confirmed by mutation status detection of L68Q
  • 4Patient has been genotyped/sequenced and confirmed to carry the L68Q mutation in the cystatin C gene
  • 5Patient is willing to have a baseline and follow up skin biopsy every 3 months for up to 9 months.
  • 6Patient has provided informed consent for participation in trial
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

  • Exclusion Criteria
  • 1\.Patient does not have L68Q mutation
  • 2\.Patient has clinically significant illness, mental or physical, that, in the opinion of the investigator, might confound the results of the study, pose additional risk to the patient by their participation, or prevent/impede the patient from completing the study.
  • 3\.Patient is pregnant or attempting to become pregnant
  • 4\.Patient tests positive for illicit drugs (including marijuana) or has history of drug abuse within the last 2 years.
  • 5\.Patient consumes excessive amounts of alcoholic beverages.
  • 6\.There is any concern by the investigator regarding the patient’s safety, compliance, or suitability with respect to his/her participation in the study.

Outcomes

Primary Outcomes

Not specified

Similar Trials

Recruiting
Not Applicable
A biomarker research of "A phase II study of second-line combination therapy with FOLFIRI plus ramucirumab in patients with RAS wild-type unresectable advanced/recurrent colorectal cancer "Colorectal cancer
JPRN-UMIN000034885Japan Clinical Cancer Research Organization (JACCRO)80
Active, not recruiting
Phase 2
A Clinical Study to evaluate the efficacy and safety of NRC-AN-019 in cancer patients failing prior standard therapiesHealth Condition 1: null- 1. Patients with metastatic or locally advanced or inoperable solid tumors who have received prior treatment2. Chronic Myeloid Leukemia patients who are resistant and/or intolerant to Imatinib
CTRI/2013/06/003768ATCO Pharma Limited
Recruiting
Phase 2
Phase II Clinical Study to evaluate the efficacy and safety of NRC-2694-AHealth Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
CTRI/2019/06/019649ATCO Pharma Ltd
Active, not recruiting
Phase 1
A phase II study assessing whether biological markers can be used to determine response to treatment with radium-223 in patients with metastatic castration resistant prostate cancer (CRPC).Castrate resistant prostate cancer with bone metastases.MedDRA version: 21.1Level: PTClassification code 10062904Term: Hormone-refractory prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10005993Term: Bone metastasesSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2013-004055-20-GBThe Royal Marsden NHS Foundation Trust38
Recruiting
Phase 2
A Phase 2, Single-Arm Study of the Biomarker Effects of ALZ-801 in Subjects with Early Alzheimer*s Disease Who Are Carriers of the *4 Variant of the Apolipoprotein E Gene (APOE4/4 or APOE3/4)Alzheimer's diseasedementia10057167
NL-OMON56257Alzheon Inc.42