TrialPanorama/Dataset huggingface dataset:
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Phase 3 Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of Bococizumab (Pf-04950615) In Reducing The Occurrence Of Major Cardiovascular Events In High Risk Subjects.
Brief Summary: This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to placebo, in reducing the occurrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization, in high risk subjects who are receiving background lipid lowering therapy and have cholesterol laboratory values of LDL-C \>/= 70 mg/dL (1.8 mmol/L) or non-HDL-C \>/= 100 mg /dL (2.6 mmol/L).


Options:
A: Arm Label: Atorvastatin (statin rechallenge arm); Type: OTHER; Interventions: Drug: Atorvastatin, Drug: Placebo | Arm Label: Ezetimibe; Type: ACTIVE_COMPARATOR; Interventions: Drug: Ezetimibe, Drug: Placebo | Arm Label: Alirocumab 75 mg/ up to 150 mg; Type: EXPERIMENTAL; Interventions: Drug: Alirocumab, Drug: Placebo | Intervention Type: DRUG; Name: Atorvastatin; Assigned to Arm(s): Atorvastatin (statin rechallenge arm) | Intervention Type: DRUG; Name: Ezetimibe; Assigned to Arm(s): Ezetimibe | Intervention Type: DRUG; Name: Alirocumab; Assigned to Arm(s): Alirocumab 75 mg/ up to 150 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Alirocumab 75 mg/ up to 150 mg, Atorvastatin (statin rechallenge arm), Ezetimibe
B: Arm Label: Bococizumab (PF-04950615;RN316); Type: EXPERIMENTAL; Interventions: Drug: Bococizumab (PF-04950615;RN316) | Arm Label: Atorvastatin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Atorvastatin | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo for Bococizumab (PF-04950615;RN316), Other: Placebo for atorvastatin | Intervention Type: DRUG; Name: Bococizumab (PF-04950615;RN316); Assigned to Arm(s): Bococizumab (PF-04950615;RN316) | Intervention Type: DRUG; Name: Atorvastatin; Assigned to Arm(s): Atorvastatin | Intervention Type: OTHER; Name: Placebo for Bococizumab (PF-04950615;RN316); Assigned to Arm(s): Placebo | Intervention Type: OTHER; Name: Placebo for atorvastatin; Assigned to Arm(s): Placebo
C: Arm Label: bococizumab (PF-04950615); Type: EXPERIMENTAL; Interventions: Drug: bococizumab (PF-04950615) | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: bococizumab (PF-04950615); Assigned to Arm(s): bococizumab (PF-04950615) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: Standard of Care; Type: ACTIVE_COMPARATOR; Interventions: Biological: Evolocumab, Other: Standard of care | Arm Label: Evolocumab + SOC; Type: EXPERIMENTAL; Interventions: Biological: Evolocumab | Intervention Type: BIOLOGICAL; Name: Evolocumab; Assigned to Arm(s): Evolocumab + SOC, Standard of Care | Intervention Type: OTHER; Name: Standard of care; Assigned to Arm(s): Standard of Care

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Phase 3 Multi Center, Double Blind, Randomized, Placebo Controlled, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of Bococizumab (Pf-04950615), In Reducing The Occurrence Of Major Cardiovascular Events In High Risk Subjects
Brief Summary: This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to placebo, in reducing the occurrrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization in high risk subjects who are receiving background lipid lowering therapy and have cholesterol laboratory values of LDL-C \>/= 100 mg/dL (2.6 mmol/L) or non-HDL-C \>/=130 mg/dL (3.4 mmol/L).


Options:
A: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo (for alirocumab), Drug: Lipid-Modifying Therapy (LMT) | Arm Label: Alirocumab; Type: EXPERIMENTAL; Interventions: Drug: Alirocumab, Drug: Lipid-Modifying Therapy (LMT) | Intervention Type: DRUG; Name: Placebo (for alirocumab); Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Alirocumab; Assigned to Arm(s): Alirocumab | Intervention Type: DRUG; Name: Lipid-Modifying Therapy (LMT); Assigned to Arm(s): Alirocumab, Placebo
B: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Evolocumab; Type: EXPERIMENTAL; Interventions: Biological: Evolocumab | Intervention Type: BIOLOGICAL; Name: Evolocumab; Assigned to Arm(s): Evolocumab | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: bococizumab (PF-04950615); Type: EXPERIMENTAL; Interventions: Drug: bococizumab (PF-04950615) | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: bococizumab (PF-04950615); Assigned to Arm(s): bococizumab (PF-04950615) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: bococizumab (PF-04950615); Type: EXPERIMENTAL; Interventions: Drug: bococizumab (PF-04950615) | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: bococizumab (PF-04950615); Assigned to Arm(s): bococizumab (PF-04950615) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Novel Use Of Hydroxyurea in an African Region With Malaria
Brief Summary: Multiple studies have shown that hydroxyurea has clinical efficacy in preventing acute painful episodes and reducing the need for blood transfusions in children with sickle cell anemia (SCA), but no study has been conducted in malaria endemic regions of sub-Saharan Africa, the areas with the most children with SCA.

The primary goal of this study is to investigate the safety and efficacy of hydroxyurea for children with SCA in a malaria endemic region within sub-Saharan Africa.


Options:
A: Arm Label: Hydroxyurea; Type: EXPERIMENTAL; Interventions: Drug: Hydroxyurea | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Hydroxyurea; Assigned to Arm(s): Hydroxyurea | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: Hydroxyurea; Type: ACTIVE_COMPARATOR; Interventions: Drug: Hydroxyurea | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Hydroxyurea; Assigned to Arm(s): Hydroxyurea | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: Standard Therapy; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Treatment Arm; Type: EXPERIMENTAL; Interventions: Drug: Hydroxyurea | Intervention Type: DRUG; Name: Hydroxyurea; Assigned to Arm(s): Treatment Arm
D: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Hydroxyurea, Procedure: Phlebotomy | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Red Cell Transfusions, Procedure: Iron Chelation | Intervention Type: PROCEDURE; Name: Red Cell Transfusions; Assigned to Arm(s): 2 | Intervention Type: PROCEDURE; Name: Iron Chelation; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Hydroxyurea; Assigned to Arm(s): 1 | Intervention Type: PROCEDURE; Name: Phlebotomy; Assigned to Arm(s): 1

Answer: A
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Novel Use Of Hydroxyurea in an African Region With Malaria
Brief Summary: Multiple studies have shown that hydroxyurea has clinical efficacy in preventing acute painful episodes and reducing the need for blood transfusions in children with sickle cell anemia (SCA), but no study has been conducted in malaria endemic regions of sub-Saharan Africa, the areas with the most children with SCA.

The primary goal of this study is to investigate the safety and efficacy of hydroxyurea for children with SCA in a malaria endemic region within sub-Saharan Africa.


Options:
A: Arm Label: cohort 1 PF-04447943; Type: EXPERIMENTAL; Interventions: Drug: PDE9i | Arm Label: cohort 2 PF-04447943; Type: EXPERIMENTAL; Interventions: Drug: PDE9i | Arm Label: placebo comparator; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo for PDE9i | Arm Label: optional cohort of PF-04447943; Type: EXPERIMENTAL; Interventions: Drug: PDE9i | Intervention Type: DRUG; Name: PDE9i; Assigned to Arm(s): cohort 1 PF-04447943, optional cohort of PF-04447943 | Intervention Type: DRUG; Name: PDE9i; Assigned to Arm(s): cohort 2 PF-04447943, optional cohort of PF-04447943 | Intervention Type: DRUG; Name: placebo for PDE9i; Assigned to Arm(s): placebo comparator | Intervention Type: DRUG; Name: PDE9i; Assigned to Arm(s): optional cohort of PF-04447943
B: Arm Label: MTD Dose Escalation; Type: EXPERIMENTAL; Interventions: Drug: Hydroxyurea | Arm Label: Fixed Dose; Type: ACTIVE_COMPARATOR; Interventions: Drug: Hydroxyurea | Intervention Type: DRUG; Name: Hydroxyurea; Assigned to Arm(s): Fixed Dose, MTD Dose Escalation
C: Arm Label: Placebo Pills and Placebo Liquid; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo Pills and Placebo Liquid | Arm Label: Hydroxyurea Pills and Placebo Liquid; Type: ACTIVE_COMPARATOR; Interventions: Drug: Hydroxyurea | Arm Label: Placebo Pills and Magnesium Pidolate Liquid; Type: ACTIVE_COMPARATOR; Interventions: Drug: Magnesium Pidolate | Arm Label: Hydroxyurea Pills and Magnesium Pidolate Liquid; Type: ACTIVE_COMPARATOR; Interventions: Drug: Hydroxyurea, Drug: Magnesium Pidolate | Intervention Type: DRUG; Name: Hydroxyurea; Assigned to Arm(s): Hydroxyurea Pills and Magnesium Pidolate Liquid, Hydroxyurea Pills and Placebo Liquid | Intervention Type: DRUG; Name: Magnesium Pidolate; Assigned to Arm(s): Hydroxyurea Pills and Magnesium Pidolate Liquid, Placebo Pills and Magnesium Pidolate Liquid | Intervention Type: OTHER; Name: Placebo Pills and Placebo Liquid; Assigned to Arm(s): Placebo Pills and Placebo Liquid
D: Arm Label: Hydroxyurea; Type: EXPERIMENTAL; Interventions: Drug: Hydroxyurea | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Hydroxyurea; Assigned to Arm(s): Hydroxyurea | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo

Answer: D
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Comparison of the Effect of Folic Acid and 5-methyltetrahydrofolate (5MTHF) on Serum Folate and Homocysteine Levels, and Abortion Rates in Women Suffering From Recurrent Abortion
Brief Summary: Recent data indicates that 5 methyltetrahydrofolate (5MTHF) can reduce serum homocystein level more efficiently than folic acid. On the other hand, folic acid is currently an important part of treatment in idiopathic recurrent abortion. There is no study comparing the effectiveness of these supplements in the treatment of recurrent abortion. The aim of this study is to compare the efficiency of these two agents in the treatment of recurrent abortion. In this study, patients with idiopathic recurrent abortion, referring to Avicenna clinic will be randomly allocated into two groups of those taking either folic acid (5 mg) or 5 MTHF (5mg) from 8 weeks prior to conception until the 20th week of pregnancy. The serum level of folate, homocystein, and ongoing pregnancy will be analysed and compared in the two groups.


Options:
A: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Iron (27 mg) - folic acid (600 ug) | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Multiple micronutrient | Intervention Type: DIETARY_SUPPLEMENT; Name: Iron (27 mg) - folic acid (600 ug); Assigned to Arm(s): 1 | Intervention Type: DIETARY_SUPPLEMENT; Name: Multiple micronutrient; Assigned to Arm(s): 2
B: Arm Label: Multivitamins; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Multivitamins-vitamins B-complex, C, and E | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Multivitamins-vitamins B-complex, C, and E; Assigned to Arm(s): Multivitamins | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: 400 micrograms of folic acid; Type: ACTIVE_COMPARATOR; Interventions: Drug: Folic acid: 4 mg versus 0.4 mg per day | Arm Label: 4mg of folic acid; Type: ACTIVE_COMPARATOR; Interventions: Drug: Folic acid: 4 mg versus 0.4 mg per day | Intervention Type: DRUG; Name: Folic acid: 4 mg versus 0.4 mg per day; Assigned to Arm(s): 400 micrograms of folic acid, 4mg of folic acid
D: Arm Label: 5-methyltetrahydrofolate; Type: EXPERIMENTAL; Interventions: Dietary Supplement: 5-methyltetrahydrofolate | Arm Label: folic acid; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: folic Acid | Intervention Type: DIETARY_SUPPLEMENT; Name: 5-methyltetrahydrofolate; Assigned to Arm(s): 5-methyltetrahydrofolate | Intervention Type: DIETARY_SUPPLEMENT; Name: folic Acid; Assigned to Arm(s): folic acid

Answer: D
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Screening of Low Responders for Aneuploidy to Improve Reproductive Efficiency
Brief Summary: The purpose of this study is to assess the impact of Comprehensive Chromosome Screening(CCS) on patients with low ovarian reserve in an effort to improve success during in vitro fertilization and decrease the time to successful pregnancy.


Options:
A: Intervention Type: PROCEDURE; Name: Endometrial biopsy; Assigned to Arm(s): N/A
B: Arm Label: With PGS 2.0; Type: EXPERIMENTAL; Interventions: Procedure: IVF/ICSI, Genetic: PGS 2.0 | Arm Label: Without PGS 2.0; Type: ACTIVE_COMPARATOR; Interventions: Procedure: IVF/ICSI, Other: Conventional embryo morphology evaluation | Intervention Type: PROCEDURE; Name: IVF/ICSI; Assigned to Arm(s): With PGS 2.0, Without PGS 2.0 | Intervention Type: GENETIC; Name: PGS 2.0; Assigned to Arm(s): With PGS 2.0 | Intervention Type: OTHER; Name: Conventional embryo morphology evaluation; Assigned to Arm(s): Without PGS 2.0
C: Arm Label: PGS (genetic screening); Type: EXPERIMENTAL; Interventions: Diagnostic Test: Preimplantation Genetic Screening | Arm Label: no PGS (no genetic screening); Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DIAGNOSTIC_TEST; Name: Preimplantation Genetic Screening; Assigned to Arm(s): PGS (genetic screening)
D: Arm Label: Embryo Transfer with CCS; Type: OTHER; Interventions: Other: Comprehensive Chromosomal Screening | Arm Label: Embryo Transfer without CCS; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Comprehensive Chromosomal Screening; Assigned to Arm(s): Embryo Transfer with CCS

Answer: D
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: The Effectiveness and Cost-effectiveness of a Task Sharing Counseling Intervention by Community Health Workers for Prenatal Depression in South Africa
Brief Summary: The objective of this randomised controlled trial (RCT) is to determine the effectiveness and cost-effectiveness of a task sharing counseling intervention for maternal depression in South Africa(i.e. provided by non-specialist health workers)


Options:
A: Arm Label: ARM 1: Component-Based Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Common Elements Treatment Approach | Arm Label: ARM 2: Community Group Therapy; Type: EXPERIMENTAL; Interventions: Behavioral: Narrative Community Group Therapy | Arm Label: ARM 3: Standby group; Type: OTHER; Interventions: Other: Standby group | Intervention Type: BEHAVIORAL; Name: Common Elements Treatment Approach; Assigned to Arm(s): ARM 1: Component-Based Intervention | Intervention Type: BEHAVIORAL; Name: Narrative Community Group Therapy; Assigned to Arm(s): ARM 2: Community Group Therapy | Intervention Type: OTHER; Name: Standby group; Assigned to Arm(s): ARM 3: Standby group
B: Arm Label: PND-MCI; Type: EXPERIMENTAL; Interventions: Other: multi-component intervention | Arm Label: usual care; Type: ACTIVE_COMPARATOR; Interventions: Other: Usual care | Intervention Type: OTHER; Name: multi-component intervention; Assigned to Arm(s): PND-MCI | Intervention Type: OTHER; Name: Usual care; Assigned to Arm(s): usual care
C: Arm Label: counseling intervention; Type: EXPERIMENTAL; Interventions: Behavioral: basic counselling by lay-health workers | Arm Label: Enhanced usual care; Type: ACTIVE_COMPARATOR; Interventions: Other: Enhanced usual care | Intervention Type: BEHAVIORAL; Name: basic counselling by lay-health workers; Assigned to Arm(s): counseling intervention | Intervention Type: OTHER; Name: Enhanced usual care; Assigned to Arm(s): Enhanced usual care
D: Arm Label: Healthy Living Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Healthy Living Intervention | Arm Label: Enhanced Standard Care Model; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: Healthy Living Intervention | Intervention Type: BEHAVIORAL; Name: Healthy Living Intervention; Assigned to Arm(s): Enhanced Standard Care Model, Healthy Living Intervention

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase IIB, Randomized, Blinded, Dose-ranging, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Dose Response Relationship of GSK1278863 Over the First 4 Weeks of Treatment and Evaluate the Safety and Efficacy of GSK1278863 Over 24 Weeks in Hemodialysis-Dependent Subjects With Anemia Associated With Chronic Kidney Disease Who Switch From Recombinant Human Erythropoietin
Brief Summary: This study is intended to evaluate the dose-response relationship of GSK1278863 over the first 4 weeks of treatment and evaluate the safety and efficacy of GSK1278863 over 24 weeks to maintain hemoglobin (Hgb) level in hemodialysis-dependent (HDD) subjects with anemia associated with chronic kidney disease (CKD) who are switched from a stable dose of recombinant human erythropoietin (rhEPO). The data generated will enable selection of the starting dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials.


Options:
A: Arm Label: GSK1278863 4 mg; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: GSK1278863 6 mg; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: GSK1278863 8 mg; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: GSK1278863 10 mg; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: GSK1278863 12 mg; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Drug: Placebo, Drug: rhEPO | Intervention Type: DRUG; Name: GSK1278863; Assigned to Arm(s): GSK1278863 10 mg, GSK1278863 12 mg, GSK1278863 4 mg, GSK1278863 6 mg, GSK1278863 8 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Control | Intervention Type: DRUG; Name: rhEPO; Assigned to Arm(s): Control
B: Arm Label: Vadadustat; Type: EXPERIMENTAL; Interventions: Drug: Vadadustat | Arm Label: Darbepoetin alfa; Type: ACTIVE_COMPARATOR; Interventions: Drug: Darbepoetin alfa | Intervention Type: DRUG; Name: Vadadustat; Assigned to Arm(s): Vadadustat | Intervention Type: DRUG; Name: Darbepoetin alfa; Assigned to Arm(s): Darbepoetin alfa
C: Arm Label: Molidustat (BAY85-3934); Type: EXPERIMENTAL; Interventions: Drug: Molidustat (BAY85-3934) | Arm Label: Darbepoetin alfa; Type: ACTIVE_COMPARATOR; Interventions: Drug: Darbepoetin alfa | Intervention Type: DRUG; Name: Molidustat (BAY85-3934); Assigned to Arm(s): Molidustat (BAY85-3934) | Intervention Type: DRUG; Name: Darbepoetin alfa; Assigned to Arm(s): Darbepoetin alfa
D: Arm Label: AKB-6548 240 mg; Type: EXPERIMENTAL; Interventions: Drug: AKB-6548 | Arm Label: AKB-6548 370 mg; Type: EXPERIMENTAL; Interventions: Drug: AKB-6548 | Arm Label: AKB-6548 500 mg; Type: EXPERIMENTAL; Interventions: Drug: AKB-6548 | Arm Label: AKB-6548 630 mg; Type: EXPERIMENTAL; Interventions: Drug: AKB-6548 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: AKB-6548; Assigned to Arm(s): AKB-6548 240 mg, AKB-6548 370 mg, AKB-6548 500 mg, AKB-6548 630 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo

Answer: A
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A 24-week, Phase IIB, Randomized, Controlled, Parallel Group, Multi-center Study to Evaluate the Safety and Efficacy of GSK1278863 in Subjects With Anemia Associated With Chronic Kidney Diseases Who Are Not on Dialysis.
Brief Summary: This study will be conducted in approximately 228 subjects with anemia associated with CKD who are not on dialysis. Two groups of subjects will be enrolled into the study: Group 1: recombinant human erythropoietin (rhEPO) naive subjects; Group 2: rhEPO users, who are currently receiving rhEPO. Subjects who are rhEPO naive will be randomized to receive either GSK1278863 once daily (QD) or rhEPO in a 3:1 fashion; subjects who are receiving an rhEPO before enrolling (rhEPO users) will be randomized in a 1:1 fashion to GSK1278863 QD or to the control arm. For those randomized to the control arm, the decision around whether the subject requires rhEPO, the selection of the type of rhEPO (if needed) and the choice of rhEPO dose to achieve and maintain Hgb concentrations within the target range should be based on Investigator clinical judgment, with the historical rhEPO dose and the current Hgb value being considered. The study consists of a screening phase of at least 4 weeks, a 24-week treatment phase and a follow-up visit that will occur approximately 4 weeks after completing treatment. It is anticipated that the data generated will enable selection of the starting dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials.


Options:
A: Arm Label: Roxadustat; Type: EXPERIMENTAL; Interventions: Drug: Roxadustat | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Roxadustat; Assigned to Arm(s): Roxadustat | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: GSK1278863; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: Control; Type: OTHER; Interventions: Drug: rhEPO | Intervention Type: DRUG; Name: GSK1278863; Assigned to Arm(s): GSK1278863 | Intervention Type: DRUG; Name: rhEPO; Assigned to Arm(s): Control
C: Arm Label: AKB-6548; Type: EXPERIMENTAL; Interventions: Drug: AKB-6548 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: AKB-6548; Assigned to Arm(s): AKB-6548 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: 0.5 mg GSK1278863; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: 2 mg GSK1278863; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: 5 mg GSK1278863; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: rhEPO; Type: ACTIVE_COMPARATOR; Interventions: Drug: rhEPO | Intervention Type: DRUG; Name: GSK1278863; Assigned to Arm(s): 0.5 mg GSK1278863, 2 mg GSK1278863, 5 mg GSK1278863 | Intervention Type: DRUG; Name: rhEPO; Assigned to Arm(s): rhEPO

Answer: B