Clinical Study of Z-213 in Subjects With Iron-deficiency... | NCT02828319

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

NCT02828319

Sponsor

Zeria Pharmaceutical

Status

Completed

Last Update Posted

Mar 6, 2018Actual

Enrollment

39Actual

Phase

Phase 3

Conditions

Iron Deficiency Anemia

Interventions

Z-213

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016

Primary Completion Date

May 2017Actual

Completion Date

Dec 2017Actual

First Submitted Date

Jun 23, 2016

First Submission Date that Met QC Criteria

Jul 6, 2016

First Posted Date

Jul 11, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2018

Last Update Posted Date

Mar 6, 2018Actual

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Z-213	Experimental		Drug: Z-213

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Z-213	Drug	The total iron dosage is calculated based on hemoglobin value and the patients' weight, IV on day 1, 8 and 15 (if needed)	Z-213

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with Adverse Drug Reactions		12 weeks
Number of participants with Adverse Events		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Maximum change in Hb value		12 weeks
Change in Hb value		12 weeks
Proportion of responders

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018798	Anemia, Iron-Deficiency

Ancestor Terms

ID	Term
D000747	Anemia, Hypochromic
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided