TrialPanorama/Dataset huggingface dataset:
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Prevention of NEC in Preterm Infants With B. Lactis
Brief Summary: The purpose of the trial is to demonstrate the effect of B. lactis in reducing the incidence of Necrotizing Enterocolitis (NEC) compared to placebo in preterm infants.


Options:
A: Arm Label: Probiotics; Type: EXPERIMENTAL; Interventions: Drug: Bifico | Intervention Type: DRUG; Name: Bifico; Assigned to Arm(s): Probiotics
B: Arm Label: "Milk" containing B. Lactis; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Probiotic supplementation | Arm Label: "Milk" containing placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Milk containing placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Probiotic supplementation; Assigned to Arm(s): "Milk" containing B. Lactis | Intervention Type: DIETARY_SUPPLEMENT; Name: Milk containing placebo; Assigned to Arm(s): "Milk" containing placebo
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: VSL#3 | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: VSL#3; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 2
D: Arm Label: probiotics group; Type: EXPERIMENTAL; Interventions: Dietary Supplement: probiotics | Arm Label: control group; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: glucose solution | Intervention Type: DIETARY_SUPPLEMENT; Name: probiotics; Assigned to Arm(s): probiotics group | Intervention Type: DIETARY_SUPPLEMENT; Name: glucose solution; Assigned to Arm(s): control group

Answer: B
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Prevention of NEC in Preterm Infants With B. Lactis
Brief Summary: The purpose of the trial is to demonstrate the effect of B. lactis in reducing the incidence of Necrotizing Enterocolitis (NEC) compared to placebo in preterm infants.


Options:
A: Arm Label: "Milk" containing B. Lactis; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Probiotic supplementation | Arm Label: "Milk" containing placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Milk containing placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Probiotic supplementation; Assigned to Arm(s): "Milk" containing B. Lactis | Intervention Type: DIETARY_SUPPLEMENT; Name: Milk containing placebo; Assigned to Arm(s): "Milk" containing placebo
B: Arm Label: probiotics group; Type: EXPERIMENTAL; Interventions: Dietary Supplement: probiotics | Arm Label: control group; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: glucose solution | Intervention Type: DIETARY_SUPPLEMENT; Name: probiotics; Assigned to Arm(s): probiotics group | Intervention Type: DIETARY_SUPPLEMENT; Name: glucose solution; Assigned to Arm(s): control group
C: Arm Label: Saccharomyces boulardii; Type: EXPERIMENTAL; Interventions: Drug: Saccharomyces boulardii | Arm Label: control; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Saccharomyces boulardii; Assigned to Arm(s): Saccharomyces boulardii | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): control
D: Arm Label: Bifidobacterium lactis; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Bifidobacterium lactis plus İnülin, Other: Maltodextrin, Dietary Supplement: İnulin | Arm Label: İnulin; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Bifidobacterium lactis, Dietary Supplement: Bifidobacterium lactis plus İnülin, Other: Maltodextrin | Arm Label: Maltodextrin; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Bifidobacterium lactis, Dietary Supplement: Bifidobacterium lactis plus İnülin, Dietary Supplement: İnulin | Arm Label: Bifidobacterium lactis plus İnülin; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Bifidobacterium lactis, Other: Maltodextrin, Dietary Supplement: İnulin | Intervention Type: DIETARY_SUPPLEMENT; Name: Bifidobacterium lactis; Assigned to Arm(s): Bifidobacterium lactis plus İnülin, Maltodextrin, İnulin | Intervention Type: DIETARY_SUPPLEMENT; Name: Bifidobacterium lactis plus İnülin; Assigned to Arm(s): Bifidobacterium lactis, Maltodextrin, İnulin | Intervention Type: OTHER; Name: Maltodextrin; Assigned to Arm(s): Bifidobacterium lactis, Bifidobacterium lactis plus İnülin, İnulin | Intervention Type: DIETARY_SUPPLEMENT; Name: İnulin; Assigned to Arm(s): Bifidobacterium lactis, Bifidobacterium lactis plus İnülin, Maltodextrin

Answer: A
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Prevention of NEC in Preterm Infants With B. Lactis
Brief Summary: The purpose of the trial is to demonstrate the effect of B. lactis in reducing the incidence of Necrotizing Enterocolitis (NEC) compared to placebo in preterm infants.


Options:
A: Arm Label: Active; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Bifidobacterium bifidum supplementation | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Placebo contains dextrin | Intervention Type: DIETARY_SUPPLEMENT; Name: Bifidobacterium bifidum supplementation; Assigned to Arm(s): Active | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo contains dextrin; Assigned to Arm(s): Placebo
B: Arm Label: "Milk" containing B. Lactis; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Probiotic supplementation | Arm Label: "Milk" containing placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Milk containing placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Probiotic supplementation; Assigned to Arm(s): "Milk" containing B. Lactis | Intervention Type: DIETARY_SUPPLEMENT; Name: Milk containing placebo; Assigned to Arm(s): "Milk" containing placebo
C: Arm Label: Saccharomyces boulardii; Type: EXPERIMENTAL; Interventions: Drug: Saccharomyces boulardii | Arm Label: control; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Saccharomyces boulardii; Assigned to Arm(s): Saccharomyces boulardii | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): control
D: Arm Label: probiotics group; Type: EXPERIMENTAL; Interventions: Dietary Supplement: probiotics | Arm Label: control group; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: glucose solution | Intervention Type: DIETARY_SUPPLEMENT; Name: probiotics; Assigned to Arm(s): probiotics group | Intervention Type: DIETARY_SUPPLEMENT; Name: glucose solution; Assigned to Arm(s): control group

Answer: B
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomised, Multi-centre, Double-blind, Placebo-controlled Trial of Vitamin D Supplementation in Adult and Adolescent Patients With Asthma
Brief Summary: The study null hypothesis is that vitamin D supplementation will not influence time to upper respiratory tract infection or time to severe asthma exacerbation in adult and adolescent patients with asthma.


Options:
A: Arm Label: vitamin D3; Type: EXPERIMENTAL; Interventions: Drug: vitamin D3 4000 IU | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: vitamin D3 4000 IU; Assigned to Arm(s): vitamin D3 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): placebo
B: Arm Label: Vigantol oil; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Cholecalciferol | Arm Label: Miglyol oil; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Miglyol oil | Intervention Type: DIETARY_SUPPLEMENT; Name: Cholecalciferol; Assigned to Arm(s): Vigantol oil | Intervention Type: DIETARY_SUPPLEMENT; Name: Miglyol oil; Assigned to Arm(s): Miglyol oil
C: Arm Label: 2000 IU per day vitamin D; Type: EXPERIMENTAL; Interventions: Drug: Vitamin D3 - Cholecalciferol 2000 IU | Arm Label: 400 IU per day vitamin D; Type: ACTIVE_COMPARATOR; Interventions: Drug: Vitamin D - Cholecalciferol 400 IU | Intervention Type: DRUG; Name: Vitamin D - Cholecalciferol 400 IU; Assigned to Arm(s): 400 IU per day vitamin D | Intervention Type: DRUG; Name: Vitamin D3 - Cholecalciferol 2000 IU; Assigned to Arm(s): 2000 IU per day vitamin D
D: Arm Label: Vitamin D3 + fish oil; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Vitamin D3, Dietary Supplement: fish oil | Arm Label: Vitamin D3 + fish oil placebo; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Vitamin D3, Dietary Supplement: Fish oil placebo | Arm Label: Vitamin D3 placebo + fish oil; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: fish oil, Dietary Supplement: Vitamin D3 placebo | Arm Label: Vitamin D3 placebo + fish oil placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Vitamin D3 placebo, Dietary Supplement: Fish oil placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin D3; Assigned to Arm(s): Vitamin D3 + fish oil, Vitamin D3 + fish oil placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: fish oil; Assigned to Arm(s): Vitamin D3 + fish oil, Vitamin D3 placebo + fish oil | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin D3 placebo; Assigned to Arm(s): Vitamin D3 placebo + fish oil, Vitamin D3 placebo + fish oil placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Fish oil placebo; Assigned to Arm(s): Vitamin D3 + fish oil placebo, Vitamin D3 placebo + fish oil placebo

Answer: B
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomised, Multi-centre, Double-blind, Placebo-controlled Trial of Vitamin D Supplementation in Adult and Adolescent Patients With Asthma
Brief Summary: The study null hypothesis is that vitamin D supplementation will not influence time to upper respiratory tract infection or time to severe asthma exacerbation in adult and adolescent patients with asthma.


Options:
A: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: D-cure | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: D-cure; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 2
B: Arm Label: Ciclesonide + placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Ciclesonide | Arm Label: Ciclesonide + Vitamin D; Type: EXPERIMENTAL; Interventions: Drug: Vitamin D3, Drug: Ciclesonide | Intervention Type: DRUG; Name: Vitamin D3; Assigned to Arm(s): Ciclesonide + Vitamin D | Intervention Type: DRUG; Name: Ciclesonide; Assigned to Arm(s): Ciclesonide + Vitamin D, Ciclesonide + placebo
C: Arm Label: 2000 IU per day vitamin D; Type: EXPERIMENTAL; Interventions: Drug: Vitamin D3 - Cholecalciferol 2000 IU | Arm Label: 400 IU per day vitamin D; Type: ACTIVE_COMPARATOR; Interventions: Drug: Vitamin D - Cholecalciferol 400 IU | Intervention Type: DRUG; Name: Vitamin D - Cholecalciferol 400 IU; Assigned to Arm(s): 400 IU per day vitamin D | Intervention Type: DRUG; Name: Vitamin D3 - Cholecalciferol 2000 IU; Assigned to Arm(s): 2000 IU per day vitamin D
D: Arm Label: Vigantol oil; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Cholecalciferol | Arm Label: Miglyol oil; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Miglyol oil | Intervention Type: DIETARY_SUPPLEMENT; Name: Cholecalciferol; Assigned to Arm(s): Vigantol oil | Intervention Type: DIETARY_SUPPLEMENT; Name: Miglyol oil; Assigned to Arm(s): Miglyol oil

Answer: D
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: NN5401-3594: A 26-week, Open-labelled, Two-arm, Parallel, Randomised Trial Comparing Efficacy and Safety of NN5401 Once Daily Plus Insulin Aspart vs. Basal-bolus Treatment With Insulin Detemir Plus Insulin Aspart in Subjects With Type 1 Diabetes / NN5401-3645: An Extension Trial Comparing Safety and Efficacy of NN5401 Plus Meal-time Insulin Aspart for the Remaining Meals With Insulin Detemir Plus Meal-time Insulin Aspart in Type 1 Diabetes (BOOST™: T1)
Brief Summary: This trial is conducted in Europe, Oceania, and the United States of America (USA).

The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin detemir (IDet) plus insulin aspart in patients with type 1 diabetes (main period) followed by the extension period comparing the long-term safety of NN5401 plus insulin aspart with insulin detemir plus insulin aspart.

The main period is registered internally at Novo Nordisk as NN5401-3594 while the extension period is registered as NN5401-3645.


Options:
A: Arm Label: Insulin Degludec + Insulin Aspart; Type: EXPERIMENTAL; Interventions: Drug: insulin degludec, Drug: insulin aspart | Arm Label: Insulin Detemir +Insulin Aspart; Type: EXPERIMENTAL; Interventions: Drug: insulin detemir, Drug: insulin aspart | Intervention Type: DRUG; Name: insulin degludec; Assigned to Arm(s): Insulin Degludec + Insulin Aspart | Intervention Type: DRUG; Name: insulin detemir; Assigned to Arm(s): Insulin Detemir +Insulin Aspart | Intervention Type: DRUG; Name: insulin aspart; Assigned to Arm(s): Insulin Degludec + Insulin Aspart, Insulin Detemir +Insulin Aspart
B: Arm Label: Insulin glargine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Insulin aspart/glargine | Arm Label: Insulin degludec; Type: EXPERIMENTAL; Interventions: Drug: Insulin aspart/degludec | Intervention Type: DRUG; Name: Insulin aspart/glargine; Assigned to Arm(s): Insulin glargine | Intervention Type: DRUG; Name: Insulin aspart/degludec; Assigned to Arm(s): Insulin degludec
C: Arm Label: IDegAsp OD; Type: EXPERIMENTAL; Interventions: Drug: insulin degludec/insulin aspart, Drug: insulin aspart | Arm Label: IDet; Type: ACTIVE_COMPARATOR; Interventions: Drug: insulin detemir, Drug: insulin aspart | Intervention Type: DRUG; Name: insulin degludec/insulin aspart; Assigned to Arm(s): IDegAsp OD | Intervention Type: DRUG; Name: insulin detemir; Assigned to Arm(s): IDet | Intervention Type: DRUG; Name: insulin aspart; Assigned to Arm(s): IDegAsp OD | Intervention Type: DRUG; Name: insulin aspart; Assigned to Arm(s): IDet
D: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: human insulin /insulin isophane | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: insulin levemir / aspart | Intervention Type: DRUG; Name: insulin levemir / aspart; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: human insulin /insulin isophane; Assigned to Arm(s): 1

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomized Trial of Rosuvastatin for Acutely Injured Lungs From Sepsis
Brief Summary: Objective: assess the efficacy and safety of oral rosuvastatin in patients with sepsis-induced Acute Lung Injury (ALI).

Hypothesis: Rosuvastatin therapy will improve mortality in patients with sepsis-induced ALI.


Options:
A: Arm Label: Sedated mechanically ventilated patients; Type: N/A; Interventions: N/A
B: Arm Label: Rosuvastatin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Rosuvastatin | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Rosuvastatin; Assigned to Arm(s): Rosuvastatin | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: Dexmedetomidine; Type: EXPERIMENTAL; Interventions: Drug: Dexmedetomidine | Arm Label: Propofol; Type: ACTIVE_COMPARATOR; Interventions: Drug: Propofol | Intervention Type: DRUG; Name: Dexmedetomidine; Assigned to Arm(s): Dexmedetomidine | Intervention Type: DRUG; Name: Propofol; Assigned to Arm(s): Propofol
D: Arm Label: A - placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Arm Label: B; Type: ACTIVE_COMPARATOR; Interventions: Drug: Ziprasidone | Arm Label: C; Type: ACTIVE_COMPARATOR; Interventions: Drug: Haloperidol | Intervention Type: DRUG; Name: Ziprasidone; Assigned to Arm(s): B | Intervention Type: DRUG; Name: Haloperidol; Assigned to Arm(s): C | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): A - placebo

Answer: B
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomized Trial of Rosuvastatin for Acutely Injured Lungs From Sepsis
Brief Summary: Objective: assess the efficacy and safety of oral rosuvastatin in patients with sepsis-induced Acute Lung Injury (ALI).

Hypothesis: Rosuvastatin therapy will improve mortality in patients with sepsis-induced ALI.


Options:
A: Arm Label: Mesenchymal stem cell arm; Type: EXPERIMENTAL; Interventions: Drug: Mesenchymal stem cells | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Mesenchymal stem cells; Assigned to Arm(s): Mesenchymal stem cell arm | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
B: Intervention Type: DRUG; Name: Mythylprednisolone; Assigned to Arm(s): N/A
C: Arm Label: Rosuvastatin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Rosuvastatin | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Rosuvastatin; Assigned to Arm(s): Rosuvastatin | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: Part A; Type: EXPERIMENTAL; Interventions: Drug: Dose 1 GSK2586881, Drug: Dose 2 GSK2586881, Drug: Dose 3 GSK2586881, Drug: Dose 4 GSK2586881 | Arm Label: Part B; Type: EXPERIMENTAL; Interventions: Drug: Dose 3 GSK2586881, Drug: Placebo (saline) | Intervention Type: DRUG; Name: Dose 1 GSK2586881; Assigned to Arm(s): Part A | Intervention Type: DRUG; Name: Dose 2 GSK2586881; Assigned to Arm(s): Part A | Intervention Type: DRUG; Name: Dose 3 GSK2586881; Assigned to Arm(s): Part A, Part B | Intervention Type: DRUG; Name: Dose 4 GSK2586881; Assigned to Arm(s): Part A | Intervention Type: DRUG; Name: Placebo (saline); Assigned to Arm(s): Part B

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: An Open Label Dose-Escalation Study Of A Self Complementary Adeno-Associated Viral Vector (scAAV 2/8-LP1-hFIXco) For Gene Transfer in Hemophilia B
Brief Summary: The purpose of this study is to determine the safety of giving a normal factor IX gene to treat individuals who have an abnormal or no factor IX gene. Recruitment will be limited to adults (≥ 18 years) with a confirmed diagnosis of hemophilia B (HB), resulting from a missense mutation in the coagulation factor IX (FIX) gene or a nonsense mutation that has not been associated with an inhibitor. Only subjects who have no evidence of active hepatitis or anti-hFIX antibodies, and who have been treated/exposed to Factor IX concentrates for at least ten years and have had an average of 3 bleeding episodes per year requiring FIX administration will be enrolled. Patients will be recruited within the United States for treatment at St. Jude Children's Research Hospital, and patients will be recruited in England and other countries for treatment in London by our British collaborators.


Options:
A: Arm Label: Cohort 1; Type: EXPERIMENTAL; Interventions: Biological: Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method, Biological: PEGylated Recombinant Factor VIII | Arm Label: Cohort 2; Type: EXPERIMENTAL; Interventions: Biological: Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method, Biological: PEGylated Recombinant Factor VIII | Intervention Type: BIOLOGICAL; Name: Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method; Assigned to Arm(s): Cohort 1, Cohort 2 | Intervention Type: BIOLOGICAL; Name: PEGylated Recombinant Factor VIII; Assigned to Arm(s): Cohort 1, Cohort 2
B: Arm Label: Group 1; Type: OTHER; Interventions: Genetic: Gene Transfer, Drug: scAAV2/8-LP1-hFIXco | Intervention Type: GENETIC; Name: Gene Transfer; Assigned to Arm(s): Group 1 | Intervention Type: DRUG; Name: scAAV2/8-LP1-hFIXco; Assigned to Arm(s): Group 1
C: Arm Label: Prophylaxis; Type: EXPERIMENTAL; Interventions: Biological: Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method, Biological: PEGylated Recombinant Factor VIII | Arm Label: On-demand; Type: EXPERIMENTAL; Interventions: Biological: PEGylated Recombinant Factor VIII | Intervention Type: BIOLOGICAL; Name: Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method; Assigned to Arm(s): Prophylaxis | Intervention Type: BIOLOGICAL; Name: PEGylated Recombinant Factor VIII; Assigned to Arm(s): Prophylaxis | Intervention Type: BIOLOGICAL; Name: PEGylated Recombinant Factor VIII; Assigned to Arm(s): Prophylaxis | Intervention Type: BIOLOGICAL; Name: PEGylated Recombinant Factor VIII; Assigned to Arm(s): On-demand
D: Arm Label: SPK-9001; Type: EXPERIMENTAL; Interventions: Biological: SPK-9001 | Intervention Type: BIOLOGICAL; Name: SPK-9001; Assigned to Arm(s): SPK-9001

Answer: B
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: An Open Label Dose-Escalation Study Of A Self Complementary Adeno-Associated Viral Vector (scAAV 2/8-LP1-hFIXco) For Gene Transfer in Hemophilia B
Brief Summary: The purpose of this study is to determine the safety of giving a normal factor IX gene to treat individuals who have an abnormal or no factor IX gene. Recruitment will be limited to adults (≥ 18 years) with a confirmed diagnosis of hemophilia B (HB), resulting from a missense mutation in the coagulation factor IX (FIX) gene or a nonsense mutation that has not been associated with an inhibitor. Only subjects who have no evidence of active hepatitis or anti-hFIX antibodies, and who have been treated/exposed to Factor IX concentrates for at least ten years and have had an average of 3 bleeding episodes per year requiring FIX administration will be enrolled. Patients will be recruited within the United States for treatment at St. Jude Children's Research Hospital, and patients will be recruited in England and other countries for treatment in London by our British collaborators.


Options:
A: Arm Label: All participants; Type: EXPERIMENTAL; Interventions: Drug: BIIB031 (rFVIIIFc), Drug: FVIII (PK subgroup only) | Intervention Type: DRUG; Name: BIIB031 (rFVIIIFc); Assigned to Arm(s): All participants | Intervention Type: DRUG; Name: FVIII (PK subgroup only); Assigned to Arm(s): All participants
B: Arm Label: Cohort 1; Type: EXPERIMENTAL; Interventions: Biological: Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method, Biological: PEGylated Recombinant Factor VIII | Arm Label: Cohort 2; Type: EXPERIMENTAL; Interventions: Biological: Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method, Biological: PEGylated Recombinant Factor VIII | Intervention Type: BIOLOGICAL; Name: Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method; Assigned to Arm(s): Cohort 1, Cohort 2 | Intervention Type: BIOLOGICAL; Name: PEGylated Recombinant Factor VIII; Assigned to Arm(s): Cohort 1, Cohort 2
C: Arm Label: Group 1; Type: OTHER; Interventions: Genetic: Gene Transfer, Drug: scAAV2/8-LP1-hFIXco | Intervention Type: GENETIC; Name: Gene Transfer; Assigned to Arm(s): Group 1 | Intervention Type: DRUG; Name: scAAV2/8-LP1-hFIXco; Assigned to Arm(s): Group 1
D: Arm Label: Prophylaxis; Type: EXPERIMENTAL; Interventions: Biological: rIX-FP | Arm Label: On-demand; Type: EXPERIMENTAL; Interventions: Biological: rIX-FP | Intervention Type: BIOLOGICAL; Name: rIX-FP; Assigned to Arm(s): On-demand, Prophylaxis

Answer: C