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Clinical Study of Z-213 in Subjects With Iron-deficiency Anemia

Primary Purpose

Iron Deficiency Anemia

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

Z-213

About this trial

This is an interventional treatment trial for Iron Deficiency Anemia

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with iron deficiency anemia

Exclusion Criteria:

Patients with anemia caused by conditions other than iron deficiency
Patients with abnormal laboratory test values at screening for Serum phosphorus, Aspartate aminotransferase, Alanine aminotransferase
Patients with liver, kidney or circulatory system disease
Patients with a history or present illness that is a malignant tumor or autoimmune disease
Patients who underwent intravenous administration of an iron preparation, administration of an erythropoiesis stimulation agent or blood transfusion within 8 weeks before the screening
Patients who underwent oral administration of an iron preparation (including an over-the-counter drug or supplement) within 4 weeks before the screening

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Z-213

Arm Description

Outcomes

Primary Outcome Measures

Number of participants with Adverse Drug Reactions

Number of participants with Adverse Events

Secondary Outcome Measures

Maximum change in Hb value

Change in Hb value

Proportion of responders

Proportion of subjects with normalization in Hb value

Proportion of cumulative dosage

Number of doses to total dose achieved

Time to total dose achieved

Full Information

NCT ID

NCT02828319

First Posted

June 23, 2016

Last Updated

March 4, 2018

Sponsor

Zeria Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT02828319

Brief Title

Clinical Study of Z-213 in Subjects With Iron-deficiency Anemia

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

July 2016 (undefined)

Primary Completion Date

May 2017 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zeria Pharmaceutical

4. Oversight

5. Study Description

Brief Summary

To confirm the safety and efficacy of Z-213 until 12 weeks after start of Z-213 administration in patients with iron deficiency Anemia

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Iron Deficiency Anemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Z-213

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Z-213

Intervention Description

The total iron dosage is calculated based on hemoglobin value and the patients' weight, IV on day 1, 8 and 15 (if needed)

Primary Outcome Measure Information:

Title

Number of participants with Adverse Drug Reactions

Time Frame

12 weeks

Title

Number of participants with Adverse Events

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Maximum change in Hb value

Time Frame

12 weeks

Title

Change in Hb value

Time Frame

12 weeks

Title

Proportion of responders

Time Frame

12 weeks

Title

Proportion of subjects with normalization in Hb value

Time Frame

12 weeks

Title

Proportion of cumulative dosage

Time Frame

12 weeks

Title

Number of doses to total dose achieved

Time Frame

12 weeks

Title

Time to total dose achieved

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with iron deficiency anemia Exclusion Criteria: Patients with anemia caused by conditions other than iron deficiency Patients with abnormal laboratory test values at screening for Serum phosphorus, Aspartate aminotransferase, Alanine aminotransferase Patients with liver, kidney or circulatory system disease Patients with a history or present illness that is a malignant tumor or autoimmune disease Patients who underwent intravenous administration of an iron preparation, administration of an erythropoiesis stimulation agent or blood transfusion within 8 weeks before the screening Patients who underwent oral administration of an iron preparation (including an over-the-counter drug or supplement) within 4 weeks before the screening

Facility Information:

City

Tokyo

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

Clinical Study of Z-213 in Subjects With Iron-deficiency Anemia

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