Start Date Duration in Months Target Completion Date Actual Completion Date

Sangobion®Iron+ Non-Interventional Study to Evaluate Changes in Hemoglobin Status in Subjects with Mild to

Moderate Iron Deficiency Anemia (SANOIN Study)

SECONDARY IDENTIFICATION NUMBER

SAN-CS-60111

FDA CLINICAL TRIAL REFERENCE (CTR) NUMBER

2020-CT0530

SCIENTIFIC TITLE

Sangobion®Iron+ Non-Interventional Study to Evaluate Changes in Hemoglobin Status in Subjects with Mild to Moderate Iron Deficiency Anemia (SANOIN Study)

PROJECT DESCRIPTION

This is a Phase IV, open label, single arm, prospective, non-interventional study to evaluate the changes in hemoglobin among subjects with mild to moderate iron deficiency anemia after 90 days of daily oral treatment with a ferrous gluconate (equiv. 30 mg elemental iron per capsule) plus multivitamins/minerals formulation as directed by a prescribing physician. A total of 200 subjects with mild to moderate iron deficiency anemia will be enrolled into the study.

NUHRA DETAILS

Regime Classification Priority

2017 - 2022 Research to enhance and extend healthy lives Nutrition

PROJECT DURATION

Start Date Duration in Months Target Completion Date Actual Completion Date

2020-06-01 12 2021-06-01 0000-00-00

PROJECT STATUS

Ongoing

REASON FOR PROJECT PENDING/SUSPENSION/TERMINATION

Unspecified

IMPLEMENTING AGENCY (PRIMARY SPONSOR)

Institution Classification Region LTO #

IQVIA RDS Philippines, Inc. Private Business NCR 3000003797863

COOPERATING AGENCY (SECONDARY SPONSOR)

Institution Classification Region LTO #

IQVIA RDS Philippines, Inc. Private Business NCR 3000003797863

Institution Classification Region LTO # No records Found.

FUNDING AGENCY (SOURCES OF MONETARY OR MATERIAL SUPPORT)

Institution Amount Region

Procter & Gamble Health Germany GmbH P 15,019,033.98 Germany

CONTACT FOR PUBLIC QUERIES

Name E-Mail Phone Number Institution and Institution Address

Elena Lam QMNL.HealthRegistrymailbox@q

uintiles.com +6328783111 Unit A, 7th Floor, 8 RockwellBuilding Hidalgo Drive, Rockwell Business Center Makati 1210 Philippines

CONTACT FOR SCIENTIFIC QUERIES

Name E-Mail Phone Number Institution and Institution Address

Dr. Poonam Sule sule.p@pg.com +91 -22 6866 9104 Godrej One, 8th floor

Pirojshahnagar, Eastern Express Highway Vikhroli East Mumbai, 400079, India

IMPLEMENTING AGENCY (PRIMARY SPONSOR)

Name Expertise Affiliation

Chela Marie Romero, MD Internal Medicine South General Hospital

Christopher Joseph Soriano, MD OB-Gynecology Ateneo de Manila University, Ateneo School of

Medicine and Public Health

Maria Virginia Abalos, MD OB-Gynecology Chong Hua Hospital

Narcisa Sonia Comia, MD Internal Medicine Mary Mediatrix Medical Center

RESEARCH CLASSIFICATION

Clinical Trial

HEALTH CONDITION(S) OR PROBLEM(S) STUDIED

Iron Deficiency Anemia

PRIMARY OUTCOMES

This study aims to evaluate the changes in hemoglobin among subjects with mild to moderate iron deficiency anemia after 90 days of daily oral treatment with a ferrous gluconate (equiv. 30 mg elemental iron per capsule) plus multivitamins/minerals formulation as directed by a prescribing physician.

KEY SECONDARY OUTCOMES

1. To measure change in Hemoglobin after 14, 30, and 60 days of treatment.2. To measure change in serum ferritin concentration at End of Study (EOS).3. To assess response to treatment in relevant sub-groups defined by age, gender, and other baseline (Visit 1) parameters.4. To evaluate the impact of the treatment on subjects’ (non-pregnant) quality of life.5. To assess the tolerability and safety of the treatment drug.6. To monitor and summarize IDA symptoms by visit.

RECRUITMENT STATUS

Contact #s.: (+632) 8377534, (+632) 8377537, (+632) 8372071-80 loc. 2117, 2112 Saliksik Building, DOST Compound, Gen. Santos Ave., Bicutan Taguig City 1631 Philippines

Pending

COUNTRIES OF RECRUITMENT

Philippines

FDA DOCUMENT TRACKING NUMBER

20200207110208

FDA APPROVAL DATE

2020-03-11

ERC APPROVAL DATE

0000-00-00

TARGET SAMPLE SIZE (PHILIPPINES)

200

ACTUAL SAMPLE SIZE (PHILIPPINES)

Unspecified

REASON FOR THE DIFFERENCE BETWEEN TARGET & ACTUAL SAMPLE SIZES

Unspecified

DATE OF FIRST ENROLLMENT

01 Jun 2020

KEY INCLUSION AND EXLUSION CRITERIA (CT)

INCLUSION CRITERIA:

1. Male or female subjects willing to provide written informed consent 2. Subjects aged ≥ 15 years to ≤ 55 years

3. Subjects with known mild to moderate iron deficiency anemia as assessed by venous blood analysis of hemoglobin defined as: Subject Population Mild Anemia Moderate Anemia

Non-pregnant 11.0 - 11.9 mg/dL 8 - 10.9 mg/dL Pregnant woman (2nd trimester: 13 -28 weeks) 9.5 - 10.5 mg/dL 8.0 - 9.4 mg/dL Pregnant woman (3rd trimester: 29 weeks to term) 9.5 - 11.0 mg/dL 8.0 - 9.4 mg/dL Post Partum 11.0 - 11.9 mg/dL 8.0 - 10.9 mg/dL Men 11.0 - 12.9 mg/dL 8.0 - 10.9 mg/dL

4. Subjects with a serum ferritin value of 5. Subjects willing to comply with the prescribed treatment regimen for the duration of study participation. EXCLUSION CRITERIA:

1. Subjects with severe case of anemia requiring blood transfusions.

2. Subjects with anemia which in the opinion of the investigator is caused by known conditions other than dietary deficiency such as: o Pernicious anemia

o Sickle cell or aplastic anemia o Active peptic ulcer

o Regional enteritis o Ulcerative Colitis o Hemorrhoids o Esophageal varices o Helminthiasis

3. Subjects with serious gastrointestinal disorders, such as inflammatory bowel disease, who cannot take iron therapy by mouth. 4. Subjects with any known autoimmune disease.

5. Malnourished subjects who also have a known underlying infection which interferes with iron absorption. 6. Obese subjects with a BMI of >30 with a pre-existing condition that may interfere with iron absorption. 7. Subjects with primary or secondary haemochromatosis or who are known to have risk for iron overload. 8. Subjects with iron deficiency anemia in whom oral therapy has failed per clinical practice.

9. Subjects with bleeding disorders.

10. Subjects suffering from severe or uncontrolled systemic or metabolic diseases. 11. Pregnant women with multifetal pregnancy.

12. Subjects who were on treatment with other hematinic agents within 4 weeks before the start of the study.

13. Subjects with severe concurrent illness (cardiovascular, renal, hepatic), and with any other condition that in the opinion of the investigator does not justify the inclusion of the subject in the study.

14. Subject whose lifestyle (including diet and food intake) would, in the Investigator’s judgment affect the subject’s participation in the study. 15. Subjects who have participated in any other clinical trial in the past 30 days from the study start.

STUDY TYPE

INTERVENTION NAME

INTERVENTION DESCRIPTION

AMENDMENT APPROVAL DATE/REASONS

Classification Approval Date Reason

No records Found.

METHOD OF ALLOCATION

MASKING / BLINDING

MASKING DETAILS

ASSIGNMENT

PURPOSE

This study aims to evaluate the changes in hemoglobin among subjects with mild to moderate iron deficiency anemia after 90 days of daily oral

Contact #s.: (+632) 8377534, (+632) 8377537, (+632) 8372071-80 loc. 2117, 2112 Saliksik Building, DOST Compound, Gen. Santos Ave., Bicutan Taguig City 1631 Philippines

treatment with a ferrous gluconate (equiv. 30 mg elemental iron per capsule) plus multivitamins/minerals formulation as directed by a prescribing physician.

PHASE

Phase IV

RESEARCH UTILIZATION

Utilization Utilization Info

Publication Oral Presentation Drug Literature Posters Others Contact #s.: (+632) 8377534, (+632) 8377537, (+632) 8372071-80 loc. 2117, 2112