An Observational, Longitudinal, Prospective, Long-Term Registry Of Patients With Hypophosphatasia (HPP)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02306720 |
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Recruitment Status :
Enrolling by invitation
First Posted : December 3, 2014
Last Update Posted : August 17, 2017
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| Tracking Information | |||
|---|---|---|---|
| First Submitted Date | November 26, 2014 | ||
| First Posted Date | December 3, 2014 | ||
| Last Update Posted Date | August 17, 2017 | ||
| Actual Study Start Date | December 2014 | ||
| Estimated Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | ||
| Change History | Complete list of historical versions of study NCT02306720 on ClinicalTrials.gov Archive Site | ||
| Current Secondary Outcome Measures | Not Provided | ||
| Original Secondary Outcome Measures | Not Provided | ||
| Current Other Outcome Measures | Not Provided | ||
| Original Other Outcome Measures | Not Provided | ||
| Descriptive Information | |||
| Brief Title | An Observational, Longitudinal, Prospective, Long-Term Registry Of Patients With Hypophosphatasia (HPP) | ||
| Official Title | An Observational, Longitudinal, Prospective, Long-Term Registry Of Patients With Hypophosphatasia (HPP) | ||
| Brief Summary | To collect and evaluate long-term safety and effectiveness data in HPP patients who have/ are receiving treatment with asfotase alfa. | ||
| Detailed Description | To collect and evaluate long-term safety and effectiveness data in HPP patients who have/ are receiving treatment with asfotase alfa. | ||
| Study Type | Observational [Patient Registry] | ||
| Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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| Target Follow-Up Duration | 5 Years | ||
| Biospecimen | Not Provided | ||
| Sampling Method | Probability Sample | ||
| Study Population | Patients with Hypophosphatasia (HPP) | ||
| Condition | Hypophosphatasia (HPP) | ||
| Intervention | Not Provided | ||
| Study Groups/Cohorts | Not Provided | ||
| Publications * | Not Provided | ||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||
| Recruitment Status | Enrolling by invitation | ||
| Estimated Enrollment |
500 | ||
| Original Estimated Enrollment | Same as current | ||
| Estimated Study Completion Date | December 2019 | ||
| Estimated Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria | Inclusion Criteria: Male and female patients, of any age, with a confirmed diagnosis of HPP. Patient or legal representative is able to read and/or understand the informed consent and study questionnaires in the local language. Signed informed consent and medical records release by the patient or legal representative. Patient or patient's parent/legal representative must be willing and able to give written informed consent, and the patient must be willing to give written informed assent, if appropriate and required by local regulations. Exclusion Criteria: Currently participating in an Alexion-sponsored clinical trial or previously received asfotase alfa. Enrollment in the Registry will not exclude a patient from enrolling in a future clinical trial. |
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| Sex/Gender |
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| Ages | Child, Adult, Senior | ||
| Accepts Healthy Volunteers | No | ||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries | Australia, Canada, France, Germany, Ireland, Italy, Portugal, Russian Federation, Saudi Arabia, Spain, United Kingdom, United States | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number | NCT02306720 | ||
| Other Study ID Numbers | ALX-HPP-501 | ||
| Has Data Monitoring Committee | Not Provided | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement | Not Provided | ||
| Responsible Party | Alexion Pharmaceuticals | ||
| Study Sponsor | Alexion Pharmaceuticals | ||
| Collaborators | Not Provided | ||
| Investigators | Not Provided | ||
| PRS Account | Alexion Pharmaceuticals | ||
| Verification Date | August 2017 | ||